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Stat Profile

FDA UDI

Class II (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name
Stat Profile FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
Device Name
Stat Profile Prime Plus Calibrator Cartridge 300 Sample FDA UDI
Model / Reference
Prime Plus FDA UDI
Description
Stat Profile Prime Plus Calibrator Cartridge 300 Sample FDA UDI

Identifiers

Catalog Number
57827 FDA UDI
Primary DI / UDI-DI
00385480578271 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nova Biomedical Corporation

Sources (1)

  • FDA UDI 6f039008-825d-4b7e-99e8-617f4a7ebfd2 36 fields · synced Jun 8, 2026