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BPCO Ointment

FDA UDI

Class I (US FDA UDI)

by Brookfield Pharmaceuticals, Llc

Identity

Trade Name
BPCO Ointment FDA UDI
Generic Name
Skin semi-occlusive dressing, non-antimicrobial FDA UDI
Device Name
Class I (general controls), 510(k) exempt medical device with a product code of NAD. Per the Code of Federal Regulations, it is regulated under 21 CFR 878.4020 as an occlusive wound dressing. FDA UDI
Model / Reference
1 FDA UDI
Description
Class I (general controls), 510(k) exempt medical device with a product code of NAD. Per the Code of Federal Regulations, it is regulated under 21 CFR 878.4020 as an occlusive wound dressing. FDA UDI

Identifiers

Primary DI / UDI-DI
00371351014603 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Skin semi-occlusive dressing, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Skin semi-occlusive dressing, non-antimicrobial

BPCO Ointment by Brookfield Pharmaceuticals, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin semi-occlusive dressing, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brookfield Pharmaceuticals, Llc

Sources (1)

  • FDA UDI dd1fad18-ac42-480c-b01f-9fdc42107736 33 fields · synced May 30, 2026