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ActiGraph

FDA UDI

Class I (US FDA UDI)

by ActiGraph L.L.C.

Identity

Trade Name
ActiGraph FDA UDI
Generic Name
Ambulatory monitoring/recording system transceiver/cable FDA UDI
Device Name
The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors. FDA UDI
Model / Reference
CentrePoint Data Hub FDA UDI
Description
The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors. FDA UDI

Identifiers

Primary DI / UDI-DI
00853048008022 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Ambulatory monitoring/recording system transceiver/cable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ambulatory monitoring/recording system transceiver/cable

ActiGraph by ActiGraph L.L.C. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory monitoring/recording system transceiver/cable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ActiGraph L.L.C.

Sources (1)

  • FDA UDI 94b7c6f5-86c5-4d25-affe-5b37570b3048 33 fields · synced Jun 1, 2026