Identity
- Trade Name
- AMSure® IV Start Kit FDA UDI
- Generic Name
- Peripheral intravenous catheterization kit, non-sensing FDA UDI
- Device Name
- 1 Pre-Filled Normal Saline Flush Syringe 10 cc(sterilized)(China) 1 Extension set(sterilized)(China) 1 Alcohol prep pad(sterilized)(China) 1 Patient label(Non-sterile)(China) 1 Gauze, 2'' x 2''x2, 4 ply(sterilized)(China) 1 Mini roll of tape(Non-sterile)(China) 1 Tegaderm, 6 cm x 10 cm(sterilized)(China) 1 Tourniquet 1'' x 18'', Blue, Rolled(Non-sterile)(China) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 1 Pre-Filled Normal Saline Flush Syringe 10 cc(sterilized)(China) 1 Extension set(sterilized)(China) 1 Alcohol prep pad(sterilized)(China) 1 Patient label(Non-sterile)(China) 1 Gauze, 2'' x 2''x2, 4 ply(sterilized)(China) 1 Mini roll of tape(Non-sterile)(China) 1 Tegaderm, 6 cm x 10 cm(sterilized)(China) 1 Tourniquet 1'' x 18'', Blue, Rolled(Non-sterile)(China) FDA UDI
Identifiers
- Catalog Number
- IVSK005 FDA UDI
- Primary DI / UDI-DI
- 10704411017837 FDA UDI
- 510(k) Number
- K050654 FDA UDI
- FDA Product Code
- LRS FDA UDI
- GMDN Term
- Peripheral intravenous catheterization kit, non-sensing 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
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral intravenous catheterization kit, non-sensing
AMSure® IV Start Kit by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI 9633b8ac-ac55-4567-bbda-61b9b7284f00 35 fields · synced May 30, 2026