Identity
- Trade Name
- Catheter Passer FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- PASSER 48409 60CM DISP. CATHETER FDA UDI
- Model / Reference
- 48409 FDA UDI
- Description
- PASSER 48409 60CM DISP. CATHETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000027841 FDA UDI
- 510(k) Number
- K911382 FDA UDI
- FDA Product Code
- MAJ FDA UDIJXG FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5120 FDA UDI882.5550 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subcutaneous tunneller, single-use
Catheter Passer by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III
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
- Medtronic PS Medical
Sources (1)
- FDA UDI d9b515c2-862d-4231-b98a-3ed9cac74108 35 fields · synced May 30, 2026