Identity
- Trade Name
- ICU Medical FDA UDI
- Generic Name
- Neutral-pressure intravenous line needleless valve-connector FDA UDI
- Device Name
- MicroClave® Neutral Connector FDA UDI
- Model / Reference
- B3300 FDA UDI
- Description
- MicroClave® Neutral Connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840619045593 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
No
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
ICU Medical by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neutral-pressure intravenous line needleless valve-connector.
- Rymed — Rymed Technologies, Inc. · Class II
- Rymed — Rymed Technologies, Inc. · Class II
- Rymed — Rymed Technologies, Inc. · Class II
- Rymed — Rymed Technologies, Inc. · Class II
- Rymed — Rymed Technologies, Inc. · Class II
- Rymed — Rymed Technologies, Inc. · Class II
- NeutrArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI · Class II
- Rymed — Rymed Technologies, Inc. · Class II
Cleared under the same submission
K970855 also covers:
- AMSafe® MicroClave® Clear Neutral Connector — AMSINO INTERNATIONAL, INC.
- 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.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 9b2e246f-1f8a-4708-b8a8-f1f80babdd83 34 fields · synced May 30, 2026