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Comfort Sampler, Basic Kit

FDA UDI

Class I (US FDA UDI)

by Opti Medical Systems Inc.

Identity

Trade Name
Comfort Sampler, Basic Kit FDA UDI
Generic Name
Arterial blood sampling kit FDA UDI
Device Name
Comfort Sampler, Basic Kit FDA UDI
Model / Reference
1 FDA UDI
Description
Comfort Sampler, Basic Kit FDA UDI

Identifiers

Catalog Number
BP0610 FDA UDI
Primary DI / UDI-DI
00894472000176 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

No

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

No

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

Comfort Sampler, Basic Kit by Opti Medical Systems Inc. — 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
Opti Medical Systems Inc.

Sources (1)

  • FDA UDI c1556cd3-216b-4ad9-862b-f5ca1132930c 34 fields · synced Jun 1, 2026