Buying guide
ISO vs OEM Service for Medical Equipment — a Decision Framework
Independent service organizations vs the original equipment manufacturer: what changes, what does not, and how to decide by device type.

Laerdal

Sony9

Welch Allyn8

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Pioneer Biomedical

CryoConcepts

CryoClear Pen 161-2001 – CryoConcepts

#CRY161-2001

Device

ISO 13485

Typical: $429

1 vendor

CryoConcepts

CryoConcepts – CryOmega Multi-Use, Disposable Cryosurgical Device – 160-2003, 160-2002

#160-2002

Device

ISO 13485

Typical: $395

1 vendor

Unknown

Datascope 0012-00-1503-02 5 ECG Lead Wires 3 ft Cable Snap

#CAB-40673-TE

Device

ISO 13485

Quote on request

2 vendors

Unknown

Datascope 0012-00-1503-05 3 ECG Lead Wires 3 ft Cable Snap

#CAB-40861-TE

Device

ISO 13485

Typical: $68

3 vendors

Unknown

Datascope 0012-00-1514-02 5 ECG Lead Wires 3 ft Cable Grabber

#CAB-40751-TE

Device

ISO 13485

Typical: $76

2 vendors

DUAL Indicator Label 3/4" Circle (1000/rl) - C1023

Unknown

DUAL Indicator Label 3/4″ Circle (Roll of 1000) – C1023

Device

ISO 13485

Quote on request

1 vendor

DUAL Monitor Strip Laminated 8 (250/bx) - C1015

Unknown

DUAL Monitor Strip Laminated 8 (Box of 250) – C1015

Device

ISO 13485

Quote on request

1 vendor

ndd

EasyOne Air Spirometer – ndd – New

#NDD2500-2A

Device

ISO 13485

Quote on request

1 vendor

ndd

EasyOne Pro Pulmonary Function System – ndd – New

#NDD3000-10

Device

ISO 13485

Typical: $31,924

1 vendor

Caire

Eclipse 5 Transportable Oxygen Concentrator – Caire – New

#CAI6900BT-SEQ

Device

ISO 13485

Typical: $3,200

1 vendor

ELECTROSTEAM 26138 Contactor 3 Pole 60A - 5366

Unknown

ELECTROSTEAM 0026138 Contactor 3 Pole 60A – 5366

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM 12003 Safety Valve 1/2″ 100 PSI – 12719

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM 13068 Heater Wire Flex #8-133 AWG Black – 12715

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM 13092A Water Inlet Solenoid 3/8″ 120V – 12236

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM 20011 Hex Bolt 5/16-18 x 1 – 12712

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM 20018 Hex Nut 5/16″-18 – 12711

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM 20045A Hex Bolt 5/16″-18 x 1-1/4″ – 12713

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM NV10030 Heating Element 8.33KW 208V w/ Square Gasket – 12723

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM NV10040 Heater Element with Gasket 208V 9.95KW – 12274

Device

ISO 13485

Quote on request

1 vendor

Unknown

ELECTROSTEAM NV10047 Heater 1/4″ 9.95KW-480V 150# w/ Gasket – 12721

Device

ISO 13485

Quote on request

1 vendor

Physio-Control

EMS Summer Bundle

Device

ISO 13485

Typical: $12,495

1 vendor

Unknown

ETC 10301KIT Cable Cylinder Repair Kit 2″ Bore – 1607

Device

ISO 13485

Quote on request

1 vendor

Unknown

ETC 13572 Check Valve 1/4″ – 4921

Device

ISO 13485

Quote on request

1 vendor

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Device

Device(1,770)

Covidien Kangaroo Joey Pole Clamp 383493

Vendors offering Device

Related buying guides

ISO vs OEM Service for Medical Equipment — a Decision Framework

CryoClear Pen 161-2001 – CryoConcepts

CryoConcepts – CryOmega Multi-Use, Disposable Cryosurgical Device – 160-2003, 160-2002

Datascope 0012-00-1503-02 5 ECG Lead Wires 3 ft Cable Snap

Datascope 0012-00-1503-05 3 ECG Lead Wires 3 ft Cable Snap

Datascope 0012-00-1514-02 5 ECG Lead Wires 3 ft Cable Grabber

DUAL Indicator Label 3/4″ Circle (Roll of 1000) – C1023

DUAL Monitor Strip Laminated 8 (Box of 250) – C1015

EasyOne Air Spirometer – ndd – New

EasyOne Pro Pulmonary Function System – ndd – New

Eclipse 5 Transportable Oxygen Concentrator – Caire – New

ELECTROSTEAM 0026138 Contactor 3 Pole 60A – 5366

ELECTROSTEAM 12003 Safety Valve 1/2″ 100 PSI – 12719

ELECTROSTEAM 13068 Heater Wire Flex #8-133 AWG Black – 12715

ELECTROSTEAM 13092A Water Inlet Solenoid 3/8″ 120V – 12236

ELECTROSTEAM 20011 Hex Bolt 5/16-18 x 1 – 12712

ELECTROSTEAM 20018 Hex Nut 5/16″-18 – 12711

ELECTROSTEAM 20045A Hex Bolt 5/16″-18 x 1-1/4″ – 12713

ELECTROSTEAM NV10030 Heating Element 8.33KW 208V w/ Square Gasket – 12723

ELECTROSTEAM NV10040 Heater Element with Gasket 208V 9.95KW – 12274

ELECTROSTEAM NV10047 Heater 1/4″ 9.95KW-480V 150# w/ Gasket – 12721

EMS Summer Bundle

ETC 10301KIT Cable Cylinder Repair Kit 2″ Bore – 1607

ETC 13572 Check Valve 1/4″ – 4921