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Holter Prep Kit

FDA UDI

Class II (US FDA UDI)

by Vectracor, Inc.

Identity

Trade Name
Holter Prep Kit FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording support kit FDA UDI
Device Name
Holter prep kit Each prep kit contains: 1 razor 1 alcohol pad 1 AA battery 1 skin scrubby 1 page of 5 wet gel electrodes 1 patient diary FDA UDI
Model / Reference
701900-00 FDA UDI
Description
Holter prep kit Each prep kit contains: 1 razor 1 alcohol pad 1 AA battery 1 skin scrubby 1 page of 5 wet gel electrodes 1 patient diary FDA UDI

Identifiers

Primary DI / UDI-DI
00857175006111 FDA UDI
FDA Product Code
OJW FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording support kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic long-term ambulatory recording support kit

Holter Prep Kit by Vectracor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording support kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vectracor, Inc.

Sources (1)

  • FDA UDI eba78a4b-0095-4cb6-8fac-7325fc6f5c94 33 fields · synced May 31, 2026