STANLEY Healthcare

FDA UDI

Class II (US FDA UDI)

by Securitas Healthcare LLC

Identity

Trade Name: STANLEY Healthcare FDA UDI
Generic Name: Ambulatory call button FDA UDI
Device Name: P10 Wi-Fi Pendant FDA UDI
Model / Reference: TAG-P1000 FDA UDI
Description: P10 Wi-Fi Pendant FDA UDI

Identifiers

Primary DI / UDI-DI: 00840948100857 FDA UDI
FDA Product Code: IQA FDA UDI
GMDN Term: Ambulatory call button FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.3725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ambulatory call button

STANLEY Healthcare by Securitas Healthcare LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Securitas Healthcare LLC

Sources (1)

FDA UDI 85f6bae4-edd2-4066-abb5-ac6e120f2858 33 fields · synced May 29, 2026