Identity
- Trade Name
- Lifeport FDA UDI
- Generic Name
- Vascular port administration set FDA UDI
- Device Name
- LifePort Infusion Set FDA UDI
- Model / Reference
- LPS 3005 FDA UDI
- Description
- LifePort Infusion Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- H787LPS30055 FDA UDI
- 510(k) Number
- K921674 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Vascular port administration set 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDILength — 1 Inch FDA UDI
Category: Vascular port administration set
Lifeport by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Port Access Kit — Bard Access Systems, Inc. · Class II
- PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC. · Class II
- Port Access Kit — Bard Access Systems, Inc. · Class II
Cleared under the same submission
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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI b3be8be8-39ce-4c51-ab43-ae23cd614c14 36 fields · synced Jun 8, 2026