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” (2.6m), 10 drops/mL, Slide and Roller Clamp, Backcheck Valve, (2) Pre-Pierced Injection Sites, Rotating Male Luer Lock with Retractable Collar, Approx. Priming Volume: 16mL FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.6m), 10 drops/mL, Slide and Roller Clamp, Backcheck Valve, (2) Pre-Pierced Injection Sites, Rotating Male Luer Lock with Retractable Collar, Approx. Priming Volume: 16mL FDA UDI
Identifiers
- Catalog Number
- FP100BI2 FDA UDI
- Primary DI / UDI-DI
- 10704411010913 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
- 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
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Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Category: Basic intravenous administration set, noninvasive
AMSafe® I.V. Administration Set 100” 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 47abfb91-6476-4b80-b522-8e6c99c9a2cb 34 fields · synced May 31, 2026