← Back to catalogue

Is72dt

FDA UDI

Class II (US FDA UDI)

by Neochild, Llc

Identity

Trade Name
IS72DT FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
Minibore Extension Set 72 inch. 2.0 mL Amber FDA UDI
Model / Reference
IS72DT FDA UDI
Description
Minibore Extension Set 72 inch. 2.0 mL Amber FDA UDI

Identifiers

Primary DI / UDI-DI
10816336020561 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

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

No

FDA UDI

Category: Intravenous administration tubing extension set

Is72dt 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Neochild, Llc

Sources (1)

  • FDA UDI e5be9bfb-1ed6-49e0-a737-305e6ed7d749 35 fields · synced Jun 8, 2026