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Regard™

FDA UDI

Class I (US FDA UDI)

by Resource Optimization & Innovation, L.l.c.

Identity

Trade Name
Regard™ FDA UDI
Generic Name
Arterial blood sampling kit FDA UDI
Device Name
A-Line 1cc Syringe 25u BH (ABG) FDA UDI
Model / Reference
ABGALN1CC-REG FDA UDI
Description
A-Line 1cc Syringe 25u BH (ABG) FDA UDI

Identifiers

Primary DI / UDI-DI
00326053118630 FDA UDI
FDA Product Code
CBT FDA UDI
GMDN Term
Arterial blood sampling kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Arterial blood sampling kit

Regard™ by Resource Optimization & Innovation, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arterial blood sampling kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resource Optimization & Innovation, L.l.c.

Sources (1)

  • FDA UDI e7dbaa25-12d2-481e-b0c1-3e4f142cf966 33 fields · synced Jun 8, 2026