Identity
- Trade Name
- AMSafe ® I.V Administration Set 100'' FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter, (1) Sure-Lok Needle-Free valve, Rotating Male Luer Lock with Retractable Collar, Approx. Priming Volume: 22mL FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter, (1) Sure-Lok Needle-Free valve, Rotating Male Luer Lock with Retractable Collar, Approx. Priming Volume: 22mL FDA UDI
Identifiers
- Catalog Number
- FP100F12Y1 FDA UDI
- Primary DI / UDI-DI
- 10704411016243 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not 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
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Serial Number
No
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Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AMSafe ® I.V Administration Set 100'' by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 7dcdda97-4b9e-4ae6-b334-83965d97180f 35 fields · synced Jun 1, 2026