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NeoMagic

FDA UDI

Class II (US FDA UDI)

by Neo Medical Inc.

Identity

Trade Name
NeoMagic FDA UDI
Generic Name
Peripheral intravenous catheterization kit, non-sensing FDA UDI
Device Name
1.9Fr x 8cm Single Lumen EPIV with Stylet (Catheter Only) FDA UDI
Model / Reference
1943-1608 FDA UDI
Description
1.9Fr x 8cm Single Lumen EPIV with Stylet (Catheter Only) FDA UDI

Identifiers

Catalog Number
1943-1608 FDA UDI
Primary DI / UDI-DI
B339194316080 FDA UDI
510(k) Number
K983916 FDA UDI
FDA Product Code
FOZ FDA UDI
GMDN Term
Peripheral intravenous catheterization kit, non-sensing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 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 Conditional FDA UDI

Dimensions & Sizes

Size
Length — 8 Centimeter FDA UDI
Catheter Gauge — 1.9 French FDA UDI

Category: Peripheral intravenous catheterization kit, non-sensing

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

Similar devices

Also classified as Peripheral intravenous catheterization kit, non-sensing.

Cleared under the same submission

K983916 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 be8d48d0-4dd7-4c6f-96ca-2e2c3daead46 38 fields · synced Jun 8, 2026