Identity
- Trade Name
- IV Start Kit FDA UDI
- Generic Name
- Peripheral intravenous catheterization support kit FDA UDI
- Device Name
- IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The procedure packs are widely used by clinical professionals using aseptic technique for patient requires Intravenous Cannula Insertion. FDA UDI
- Model / Reference
- IVSK100 FDA UDI
- Description
- IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The procedure packs are widely used by clinical professionals using aseptic technique for patient requires Intravenous Cannula Insertion. FDA UDI
Identifiers
- Catalog Number
- IVSK100 FDA UDI
- Primary DI / UDI-DI
- 09555240405210 FDA UDI
- FDA Product Code
- LRS FDA UDI
- GMDN Term
- Peripheral intravenous catheterization support kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Peripheral intravenous catheterization support kit
IV Start Kit by Itl Asia Pacific Sdn. Bhd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral intravenous catheterization support kit.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Centurion — Centurion Medical Products · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- IV Start Kit w/Catheter, 18Ga — Altitude Technologies Inc. · Class II
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Centurion — Centurion Medical Products · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Itl Asia Pacific Sdn. Bhd.
Sources (1)
- FDA UDI 11ecdc68-e83e-4d22-90ad-1fc9d9d09286 35 fields · synced May 31, 2026