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Opt-Shield Air Supine

FDA UDI

Class II (US FDA UDI)

by Bcg Medical, LLC

Identity

Trade Name
Opt-Shield Air Supine FDA UDI
Generic Name
External circulating-air core temperature regulation system pad, single-use FDA UDI
Device Name
Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities. FDA UDI
Model / Reference
OSA90X39SUP FDA UDI
Description
Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities. FDA UDI

Identifiers

Catalog Number
OSA90X39SUP FDA UDI
Primary DI / UDI-DI
00868680000310 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-air core temperature regulation system pad, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: External circulating-air core temperature regulation system pad, single-use

Opt-Shield Air Supine by Bcg Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-air core temperature regulation system pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bcg Medical, LLC

Sources (1)

  • FDA UDI 29b36ce3-8d07-4008-a7fb-c3f7770c420f 36 fields · synced Jun 8, 2026