| Primary Device ID | 20376885025013 |
| NIH Device Record Key | 3f82d365-faf8-4d67-a6e5-15dcdb27145d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoe cover (40gsm PP half elastic) [EMS-10232] |
| Version Model Number | EMS-10232 |
| Company DUNS | 117478411 |
| Company Name | Emergency Medical Solutions LLC |
| Device Count | 1000 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00376885025019 [Unit of Use] |
| GS1 | 20376885025013 [Primary] |
| FXP | Cover, Shoe, Operating-Room |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-20 |
| Device Publish Date | 2021-05-12 |
| 20376885018015 - Knee high boot covers (45g SMS) | 2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B] |
| 20376885019012 - Knee high boot covers (45g SMS) | 2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms (welded), Tie to tighten boat) [EMS-11222] |
| 20376885020018 - Knee high boot covers (45g SMS) | 2021-05-20 knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211] |
| 20376885021015 - Knee high boot cover (40g SMS) | 2021-05-20 Knee high boot cover (40g SMS + pvc non slip) [EMS-11311] |
| 20376885022012 - Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411] | 2021-05-20 Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411] |
| 20376885023019 - Shoe cover (35gsm PP half elastic) [EMS-10221] | 2021-05-20 Shoe cover (35gsm PP half elastic) [EMS-10221] |
| 20376885024016 - Shoe cover (33gsm PP full elastic) [EMS-10211] | 2021-05-20 |
| 20376885025013 - Shoe cover (40gsm PP half elastic) [EMS-10232] | 2021-05-20Shoe cover (40gsm PP half elastic) [EMS-10232] |
| 20376885025013 - Shoe cover (40gsm PP half elastic) [EMS-10232] | 2021-05-20 Shoe cover (40gsm PP half elastic) [EMS-10232] |