BPCO Ointment

GUDID 00371351014603

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.

Brookfield Pharmaceuticals, Llc

Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial Skin semi-occlusive dressing, non-antimicrobial

• Primary Device ID: 00371351014603
• NIH Device Record Key: dd1fad18-ac42-480c-b01f-9fdc42107736
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPCO Ointment
• Version Model Number: 1
• Company DUNS: 080592685
• Company Name: Brookfield Pharmaceuticals, Llc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00371351014603 [Primary]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-23
• Device Publish Date: 2023-11-15