Identity
- Trade Name
- ComfiTape FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, silicone FDA UDI
- Model / Reference
- 69250 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00714196692504 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Dressing-fixation skin adhesive tape, silicone FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 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
No
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: Dressing-fixation skin adhesive tape, silicone
ComfiTape by Dermarite Industries Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dressing-fixation skin adhesive tape, silicone.
- Acanthus — ACANTHUS MEDICAL CREATIONS, LLC · Class I
- Hydrogel Adhesive — VivaLNK, Inc. · Class I
- Silicone Bandage — AP MDS Co., Ltd. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- FifthPulse — Jeg & Sons Inc. · Class I
- OFFSET MODULAR HEAD PROVISIONAL — Biomet Orthopedics, Inc. · Class I
- Acanthus — ACANTHUS MEDICAL CREATIONS, LLC · Class I
- LotFancy — Henan Maidingkang Medical Technology Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dermarite Industries Llc
Sources (1)
- FDA UDI 51b3ce07-d912-40d0-a365-062f20c1da7c 32 fields · synced May 30, 2026