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Calibration Solution

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
Calibration Solution FDA UDI
Generic Name
Multiple blood gas analyte IVD, calibrator FDA UDI
Device Name
S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX FDA UDI
Model / Reference
944-021 FDA UDI
Description
S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX FDA UDI

Identifiers

Catalog Number
944-021 FDA UDI
Primary DI / UDI-DI
05700699440211 FDA UDI
FDA Product Code
CHL FDA UDI
CGZ FDA UDI
JFP FDA UDI
GKF FDA UDI
CGA FDA UDI
KHP FDA UDI
CIG FDA UDI
CEM FDA UDI
MQM FDA UDI
JGS FDA UDI
JJS FDA UDI
GMDN Term
Multiple blood gas analyte IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
862.1170 FDA UDI
862.1145 FDA UDI
864.5600 FDA UDI
862.1345 FDA UDI
862.1450 FDA UDI
862.1110 FDA UDI
862.1600 FDA UDI
862.1113 FDA UDI
862.1665 FDA UDI
862.1660 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple blood gas analyte IVD, calibrator

Calibration Solution by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas analyte IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA UDI 8a664a0a-11b0-4b37-87a1-ff96b4da1890 36 fields · synced Jun 1, 2026