Identity
- Trade Name
- AMSafe® MicroClave® Clear Neutral Connector FDA UDI
- Generic Name
- Neutral-pressure intravenous line needleless valve-connector FDA UDI
- Device Name
- AMSafe® MicroClave® Clear Neutral Connector, Approx Priming Volume: 0.04mL FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSafe® MicroClave® Clear Neutral Connector, Approx Priming Volume: 0.04mL FDA UDI
Identifiers
- Catalog Number
- MR4001 FDA UDI
- Primary DI / UDI-DI
- 10704411004547 FDA UDI
- 510(k) Number
- K970855 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Neutral-pressure intravenous line needleless valve-connector 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: Neutral-pressure intravenous line needleless valve-connector
AMSafe® MicroClave® Clear Neutral Connector by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K970855 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, 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 9f1c6068-bb24-407a-83b1-e6b1ccead491 35 fields · synced May 30, 2026