Identity
- Trade Name
- Chemosite FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- Low Profile Venous Access System FDA UDI
- Model / Reference
- 120023A FDA UDI
- Description
- Low Profile Venous Access System FDA UDI
Identifiers
- Catalog Number
- 120023A FDA UDI
- Primary DI / UDI-DI
- 10884521099401 FDA UDI
- 510(k) Number
- K952748 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 2 Millimeter FDA UDIOuter Diameter — 1 Millimeter FDA UDI
Chemosite by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Covidien LP
Sources (1)
- FDA UDI 377e38aa-6882-4a0d-98fb-a664c63d8192 39 fields · synced Jun 1, 2026