Wipe Down Body Wedge Set - Bariatric BPW20

GUDID 10810006680109

Bariatric Wipe Down Body Wedge Set (1 each-Short / 1 each-Long)

PRIMO INC

Freestanding patient positioner, reusable
Primary Device ID10810006680109
NIH Device Record Key6780bda8-35f7-4b2d-aee2-32fc1557c298
Commercial Distribution StatusIn Commercial Distribution
Brand NameWipe Down Body Wedge Set - Bariatric
Version Model NumberBPW20
Catalog NumberBPW20
Company DUNS958758146
Company NamePRIMO INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810006680102 [Primary]
GS110810006680109 [Package]
Contains: 00810006680102
Package: CASE [4 Units]
In Commercial Distribution

FDA Product Code

FMPProtector, Skin Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-20

On-Brand Devices [Wipe Down Body Wedge Set - Bariatric]

00810006682977Bariatric Wipe Down Body Wedge Set (2 each-BPW02C-15)
10810006680109Bariatric Wipe Down Body Wedge Set (1 each-Short / 1 each-Long)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.