myPatch®

FDA UDI

Class II (US FDA UDI)

by dms-service, LLC

Identity

Trade Name: myPatch® FDA UDI
Generic Name: Electrocardiographic ambulatory recorder FDA UDI
Device Name: 3 channel Holter recorder FDA UDI
Model / Reference: s FDA UDI
Description: 3 channel Holter recorder FDA UDI

Identifiers

Catalog Number: mp3 FDA UDI
Primary DI / UDI-DI: 00857522005019 FDA UDI
510(k) Number: K160704 FDA UDI
FDA Product Code: DSH FDA UDI
GMDN Term: Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2800 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 40 Millimeter FDA UDI
Depth — 10 Millimeter FDA UDI
Width — 49 Millimeter FDA UDI

Category: Electrocardiographic ambulatory recorder

myPatch® by dms-service, 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: dms-service, LLC

Sources (1)

FDA UDI 1d5c2b32-d422-42ff-9bef-47f2591b7ec1 38 fields · synced May 30, 2026