| Primary Device ID | 10810044961048 |
| NIH Device Record Key | 499313de-23ec-45ff-85b5-93ba0d8bfcec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prone Positioning Pillow |
| Version Model Number | 30-146-A |
| Catalog Number | 30-146-A |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810044961041 [Primary] |
| GS1 | 10810044961048 [Package] Contains: 00810044961041 Package: Case [10 Units] In Commercial Distribution |
| 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 | 2020-07-28 |
| Device Publish Date | 2020-07-20 |
| 10810044961062 | P3 Pediatric 3-5/8" X 8" X 9-1/4" |
| 10810044961055 | P3 Infant 3-1/8" x 6-1/2" X 7-1/2" |
| 10810044961048 | P3 Adult 5" X 10-1/4" X 12" |