| Primary Device ID | 10810006683995 |
| NIH Device Record Key | 96ec0afc-90ad-4600-80a1-43537a242360 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Defender - Standard |
| Version Model Number | HB100 |
| Catalog Number | HB100 |
| Company DUNS | 958758146 |
| Company Name | PRIMO INC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810006683998 [Primary] |
| GS1 | 10810006683995 [Package] Contains: 00810006683998 Package: [12 Units] In Commercial Distribution |
| FMP | Protector, Skin Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2021-06-30 |
| 10810006683513 - Economy Foam Heel Protector | 2021-08-03 Economy Foam Heel Protector |
| 10810006683520 - AirFloat Static Air Seat Cushion | 2021-08-03 AirFloat Static Air Seat Cushion (17"x17") |
| 10810006683537 - AirFloat Static Air Seat Cushion | 2021-08-03 AirFloat Static Air Seat Cushion (17"x17") with pump |
| 10810006683742 - Wipe Down Body Wedge Set | 2021-08-03 Wipe Down Body Wedge Set (1 each-BPW04F/ 1 each-BPW04FL) - 12/ST/CA |
| 10810006683759 - Wipe Down Body Wedge Set | 2021-08-03 Wipe Down Body Wedge Set (2 each - BPW04F) 12 ST/CA |
| 10810006683780 - Glide & Guide Turn System Kit | 2021-08-03 GGTS02 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10F; 12 Kit/Case |
| 10810006683797 - Glide & Guide Turn System Kit | 2021-08-03 GGTS02B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW10F; 12 Kit/Case |
| 10810006683803 - Glide & Guide Turn System Kit | 2021-08-03 GGTS01 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10R; 10 Kit/Case |