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NeoMagic

FDA UDI

Class II (US FDA UDI)

by Neo Medical Inc.

Identity

Trade Name
NeoMagic FDA UDI
Generic Name
Catheter care kit FDA UDI
Device Name
1.9Fr & 2.0Fr Repair Kit FDA UDI
Model / Reference
350-01 FDA UDI
Description
1.9Fr & 2.0Fr Repair Kit FDA UDI

Identifiers

Catalog Number
350-01 FDA UDI
Primary DI / UDI-DI
B339350010 FDA UDI
510(k) Number
K953300 FDA UDI
FDA Product Code
LJS FDA UDI
GMDN Term
Catheter care kit 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

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 2.0 French FDA UDI
Catheter Gauge — 1.9 French FDA UDI

Category: Catheter care kit

NeoMagic by Neo Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter care kit.

Cleared under the same submission

K953300 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neo Medical Inc.

Sources (1)

  • FDA UDI 64902e48-d807-4a3d-9b82-b66576d8a0c7 38 fields · synced May 30, 2026