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Amc

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name
AMC FDA UDI
Generic Name
External cuff/pad inflation tubing set, single-use FDA UDI
Device Name
NK Dual Tube to Dual Neonatal Connector FDA UDI
Model / Reference
HO-D40N26 FDA UDI
Description
NK Dual Tube to Dual Neonatal Connector FDA UDI

Identifiers

Primary DI / UDI-DI
00849593061070 FDA UDI
FDA Product Code
DXQ FDA UDI
GMDN Term
External cuff/pad inflation tubing set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External cuff/pad inflation tubing set, single-use

Amc by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External cuff/pad inflation tubing set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advantage Medical Electronics, LLC

Sources (1)

  • FDA UDI 08db1318-72e1-4e7b-9975-a8c55ded61d3 34 fields · synced Jun 1, 2026