Identity
- Trade Name
- NeoMagic FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- 1.9Fr x 25cm Single Lumen Polyurethane PICC with Stylet FDA UDI
- Model / Reference
- 1946-1625 FDA UDI
- Description
- 1.9Fr x 25cm Single Lumen Polyurethane PICC with Stylet FDA UDI
Identifiers
- Catalog Number
- 1946-1625 FDA UDI
- Primary DI / UDI-DI
- B339194616250 FDA UDI
- 510(k) Number
- K953300 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Peripherally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 25 Centimeter FDA UDICatheter Gauge — 1.9 French FDA UDI
Category: Peripherally-inserted central venous catheter
NeoMagic by Neo Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripherally-inserted central venous catheter.
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Synergy — Health Line International Corp · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- PowerPICC — Bard Access Systems, Inc. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- PowerPICC Provena — Bard Access Systems, Inc. · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
Cleared under the same submission
K953300 also covers:
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo 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
- Neo Medical Inc.
Sources (1)
- FDA UDI 646bd69a-6766-4c85-8900-f89c42b59d83 38 fields · synced Jun 1, 2026