UDI device identifier

HOMEDICS SR-160HJ

UDI device identifier 00031262108746 · FKA DISTRIBUTING CO., LLC

Key facts

Primary DI 00031262108746
Brand name HOMEDICS
Version or model SR-160HJ
Company FKA DISTRIBUTING CO., LLC
DUNS number 183280973
Product code IRP
GMDN term Pneumatic massager
Premarket submission K222949
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Aug 21, 2023
Version date Aug 29, 2023
Description Air Compression Leg Massager

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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