Covered Cushions and Wedges 60-300-00

GUDID 00810044961485

18" Molded Ring Cushion 2.75" x 15.5" x 18.5"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use
Primary Device ID00810044961485
NIH Device Record Key63edef8e-fdaa-4a16-8b04-5fad79c82659
Commercial Distribution StatusIn Commercial Distribution
Brand NameCovered Cushions and Wedges
Version Model Number60-300-00
Catalog Number60-300-00
Company DUNS964459106
Company NameGENEVA HEALTHCARE, LLC
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810044961485 [Package]
Contains: 00810044961492
Package: Case [5 Units]
In Commercial Distribution
GS100810044961492 [Primary]

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-06
Device Publish Date2020-07-29

On-Brand Devices [Covered Cushions and Wedges]

00810044961294Wheelchair Pad, Memory Foam, Cotton Cover 18" x 18" x 2"
00810044961287Wheelchair Pad, Memory Foam, Cotton Cover 18" x 16" x 2"
10810044961277Wheelchair Seat Cushion 16" X 18" X 2"
00810044961126Fall Pad 35" X 80" X 4"
00810044961119Fall Pad 35" X 70" X 2"
0081004496147816" Convoluted Ring Cushion 2" x 12" x 16"
00810044961607Ortho Knee Wedge - 10" x 19.5" x 10"
00810044961577Protective Bed Rail Pads 60" x 15" x .5" - Pair
00810044961560Coccyx Seat Cushion 2" x 16" x 18"
00810044961546Memory Foam Sloping Travel Coccyx Cushion 15" x 13.5" x 3" > 1"
00810044961539Sloping Coccyx Cushion 16" x 18" x 3" > 1"
00810044961522W/C Wedge w/ Cover 16" x 18" x 3" >1"
00810044961508Roll Pillow w/ Navy Cover 3" x 17"
0081004496148518" Molded Ring Cushion 2.75" x 15.5" x 18.5"
0081004496145416" Molded Ring Cushion 2.75"x13.25"x16.5"
0081004496141614" Molded Ring Cushion 2.25"x13"x15"
00810044961423Convolute Top 10" Bed Wedge 10" x 24" x 24"

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.