← Back to catalogue

GEM Premier 3000

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM Premier 3000 FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI
Device Name
GEM Premier 3000 (Refurbished) FDA UDI
Model / Reference
0005700R FDA UDI
Description
GEM Premier 3000 (Refurbished) FDA UDI

Identifiers

Catalog Number
0005700R FDA UDI
Primary DI / UDI-DI
08426950947356 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood gas/haemoximetry analyser IVD, laboratory

GEM Premier 3000 by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood gas/haemoximetry analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Instrumentation Laboratory Company

Sources (1)

  • FDA UDI 5e9ae809-11d0-4cb3-a57a-c868fe1d6bf4 36 fields · synced Jun 8, 2026