Identity
- Trade Name
- IV Catheter Dressings FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- 2.9" x 3.8" (7.4cm x 9.6cm) FDA UDI
- Model / Reference
- 4609 FDA UDI
- Description
- 2.9" x 3.8" (7.4cm x 9.6cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784460918 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic polymer semi-permeable film dressing, adhesive
IV Catheter Dressings by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mepore® Film — Mölnlycke Health Care AB · 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 |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI a39784c4-6f19-402f-8c40-122f95ab3ac6 33 fields · synced May 30, 2026