| Primary Device ID | 00810044961607 |
| NIH Device Record Key | e12778be-53c5-4442-bc88-c7d99017caa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Covered Cushions and Wedges |
| Version Model Number | 60-402-00 |
| Catalog Number | 60-402-00 |
| Company DUNS | 964459106 |
| Company Name | GENEVA HEALTHCARE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com | |
| Phone | 1-262-767-9870 |
| info@genevahc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810044961607 [Primary] |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-06 |
| Device Publish Date | 2020-07-29 |
| 00810044961294 | Wheelchair Pad, Memory Foam, Cotton Cover 18" x 18" x 2" |
| 00810044961287 | Wheelchair Pad, Memory Foam, Cotton Cover 18" x 16" x 2" |
| 10810044961277 | Wheelchair Seat Cushion 16" X 18" X 2" |
| 00810044961126 | Fall Pad 35" X 80" X 4" |
| 00810044961119 | Fall Pad 35" X 70" X 2" |
| 00810044961478 | 16" Convoluted Ring Cushion 2" x 12" x 16" |
| 00810044961607 | Ortho Knee Wedge - 10" x 19.5" x 10" |
| 00810044961577 | Protective Bed Rail Pads 60" x 15" x .5" - Pair |
| 00810044961560 | Coccyx Seat Cushion 2" x 16" x 18" |
| 00810044961546 | Memory Foam Sloping Travel Coccyx Cushion 15" x 13.5" x 3" > 1" |
| 00810044961539 | Sloping Coccyx Cushion 16" x 18" x 3" > 1" |
| 00810044961522 | W/C Wedge w/ Cover 16" x 18" x 3" >1" |
| 00810044961508 | Roll Pillow w/ Navy Cover 3" x 17" |
| 00810044961485 | 18" Molded Ring Cushion 2.75" x 15.5" x 18.5" |
| 00810044961454 | 16" Molded Ring Cushion 2.75"x13.25"x16.5" |
| 00810044961416 | 14" Molded Ring Cushion 2.25"x13"x15" |
| 00810044961423 | Convolute Top 10" Bed Wedge 10" x 24" x 24" |