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AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 7" attached extension set. One Split Septum Injection Site, One Needle-Free Injection Site, One Rotating Male Luer Lock Adapter Length=82”, Priming Volume=22ml Non-Pyrogenic fluid pathway. GRAVITY USE ONLY FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 7" attached extension set. One Split Septum Injection Site, One Needle-Free Injection Site, One Rotating Male Luer Lock Adapter Length=82”, Priming Volume=22ml Non-Pyrogenic fluid pathway. GRAVITY USE ONLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10704411007500 FDA UDI
- 510(k) Number
- K101958 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
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: Basic intravenous administration set, noninvasive
AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K101958 also covers:
- AMSafe-3 Non-Vented I.V. Set — AMSINO INTERNATIONAL, INC.
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber — AMSINO INTERNATIONAL, INC.
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber — AMSINO INTERNATIONAL, INC.
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber — AMSINO INTERNATIONAL, INC.
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber — AMSINO INTERNATIONAL, INC.
- AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber — AMSINO INTERNATIONAL, INC.
- AMSafe-3® I.V. Administration Set — AMSINO INTERNATIONAL, INC.
- AMSafe-3® I.V. Administration Set — AMSINO INTERNATIONAL, INC.
- AMSafe-3® I.V. Administration Set — AMSINO INTERNATIONAL, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
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 679d40a3-3872-4bb6-8dc6-8bff751ac44c 34 fields · synced May 30, 2026