Identity
- Trade Name
- UltraDressing FDA UDI
- Generic Name
- Percutaneous catheter protector, professional FDA UDI
- Model / Reference
- 330M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50686004000076 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Percutaneous catheter protector, professional 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Percutaneous catheter protector, professional
UltraDressing by I.v. House — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous catheter protector, professional.
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- GUANGYI — Jiangsu Guangyi Medical Dressing Co., LTD. · Class I
- UltraDome — I.V. HOUSE · Class I
- UltraDressing — I.V. HOUSE · Class I
- UltraDome — I.V. HOUSE · 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
- I.v. House
Sources (1)
- FDA UDI 08c91382-d495-47f0-889a-8f1411719b72 32 fields · synced Jun 6, 2026