Identity
- Trade Name
- Level 1 FDA UDI
- Generic Name
- Intravenous line recessed-needle connector FDA UDI
- Model / Reference
- PC-8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 40695085410806 FDA UDI
- 510(k) Number
- K911383 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Intravenous line recessed-needle connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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: Intravenous line recessed-needle connector
Level 1 by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K911383 also covers:
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — 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
- Icu Medical, Inc.
Sources (1)
- FDA UDI 767482ea-bfc8-42f6-b203-ec71109884e2 33 fields · synced Jun 8, 2026