Stat Profile

FDA UDI

Class II (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name: STAT PROFILE FDA UDI
Generic Name: Blood gas analyser IVD, point-of-care FDA UDI
Device Name: Remanufactured Stat Profile Phox Basic Analyzer FDA UDI
Model / Reference: PHOX BASIC FDA UDI
Description: Remanufactured Stat Profile Phox Basic Analyzer FDA UDI

Identifiers

Catalog Number: 35540 FDA UDI
Primary DI / UDI-DI: 00385480355407 FDA UDI
510(k) Number: K013729 FDA UDI
FDA Product Code: JIX FDA UDI
JPK FDA UDI
CHL FDA UDI
GMDN Term: Blood gas analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
864.8625 FDA UDI
862.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood gas analyser IVD, point-of-care

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

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Cleared under the same submission

K013729 also covers:

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: Nova Biomedical Corporation

Sources (1)

FDA UDI 1b32430a-28b3-4a56-83e8-7bf2b14c52bf 37 fields · synced Jun 8, 2026