Stat Profile

FDA UDI

Class I (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name: STAT PROFILE FDA UDI
Generic Name: Co-oximetry analyser IVD, point-of-care FDA UDI
Device Name: Stat Profile Critical Care Express CO-Oximeter Analyzer FDA UDI
Model / Reference: CCX CO OX FDA UDI
Description: Stat Profile Critical Care Express CO-Oximeter Analyzer FDA UDI

Identifiers

Catalog Number: 37413 FDA UDI
Primary DI / UDI-DI: 00385480374132 FDA UDI
510(k) Number: K061830 FDA UDI
FDA Product Code: JJS FDA UDI
JIX FDA UDI
CGA FDA UDI
CIG FDA UDI
CHL FDA UDI
GKR FDA UDI
CDS FDA UDI
CGZ FDA UDI
JPI FDA UDI
CGL FDA UDI
JJY FDA UDI
JPK FDA UDI
CEM FDA UDI
JFP FDA UDI
JKS FDA UDI
KHP FDA UDI
CFA FDA UDI
GHS FDA UDI
JGS FDA UDI
JIT FDA UDI
GMDN Term: Co-oximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1150 FDA UDI
862.1345 FDA UDI
862.1110 FDA UDI
862.1120 FDA UDI
864.5620 FDA UDI
862.1770 FDA UDI
862.1170 FDA UDI
864.6400 FDA UDI
862.1225 FDA UDI
864.8625 FDA UDI
862.1600 FDA UDI
862.1145 FDA UDI
862.3220 FDA UDI
862.1450 FDA UDI
862.1495 FDA UDI
864.7425 FDA UDI
862.1665 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: Co-oximetry analyser IVD, point-of-care

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

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Avoximeter Whole Blood Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Specials — SeaSpine Orthopedics Corporation · Class I
Specials — SeaSpine Orthopedics Corporation · Class I
Avoximeter Whole Blood Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II

Cleared under the same submission

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 I	Pending data

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Manufacturer

Manufacturer: Nova Biomedical Corporation

Sources (1)

FDA UDI 00aaa5ed-7c03-404c-838c-0e5c1382bbd1 37 fields · synced Jun 8, 2026