Amc

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name: AMC FDA UDI
Generic Name: Blood pressure cuff, single-use FDA UDI
Device Name: Disposable Cuff, Single Tube, Adult, HP Fitting FDA UDI
Model / Reference: CU-ST2635HP-20 FDA UDI
Description: Disposable Cuff, Single Tube, Adult, HP Fitting FDA UDI

Identifiers

Primary DI / UDI-DI: 00849593007429 FDA UDI
510(k) Number: K063863 FDA UDI
FDA Product Code: DXQ FDA UDI
GMDN Term: Blood pressure cuff, 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Blood pressure cuff, single-use

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

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Also classified as Blood pressure cuff, single-use.

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Medline — MEDLINE INDUSTRIES, INC. · Class II
Softcheck — STATCORP MEDICAL · Class II
Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class II
MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Advantage Medical Electronics, LLC

Sources (1)

FDA UDI 2858a08e-19b0-4035-babd-20a37b3ce75c 35 fields · synced Jun 1, 2026