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Is10112

FDA UDI

Class II (US FDA UDI)

by Neochild, Llc

Identity

Trade Name
IS10112 FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
IV Extension Set 112" with 10 Drop Vented Chamber FDA UDI
Model / Reference
IS10112 FDA UDI
Description
IV Extension Set 112" with 10 Drop Vented Chamber FDA UDI

Identifiers

Primary DI / UDI-DI
10816336022480 FDA UDI
510(k) Number
K003854 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Intravenous administration tubing extension set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

No

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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Intravenous administration tubing extension set

Is10112 by Neochild, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Cleared under the same submission

K003854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neochild, Llc

Sources (1)

  • FDA UDI 5ebcb988-1f15-411a-a0c0-aed2acd093b7 35 fields · synced May 31, 2026