Crea Calibration Solution 1

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name: Crea Calibration Solution 1 FDA UDI
Generic Name: Multiple blood gas analyte IVD, calibrator FDA UDI
Device Name: S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA FDA UDI
Model / Reference: 944-135 FDA UDI
Description: S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA FDA UDI

Identifiers

Catalog Number: 944-135 FDA UDI
Primary DI / UDI-DI: 05700699441355 FDA UDI
FDA Product Code: CGL FDA UDI
CIG FDA UDI
JFP FDA UDI
CGZ FDA UDI
MQM FDA UDI
CEM FDA UDI
CHL FDA UDI
JGS FDA UDI
KHP FDA UDI
CGA FDA UDI
GHS FDA UDI
KQI FDA UDI
GMDN Term: Multiple blood gas analyte IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1225 FDA UDI
862.1110 FDA UDI
862.1145 FDA UDI
862.1170 FDA UDI
862.1113 FDA UDI
862.1600 FDA UDI
862.1120 FDA UDI
862.1665 FDA UDI
862.1450 FDA UDI
862.1345 FDA UDI
864.7425 FDA UDI
864.7455 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple blood gas analyte IVD, calibrator

Crea Calibration Solution 1 by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Radiometer Medical ApS

Sources (1)

FDA UDI 4eeb51a0-44c5-4cfa-ac5a-82c3583922b2 36 fields · synced Jun 8, 2026