| Primary Device ID | 00850037694808 |
| NIH Device Record Key | e40235c0-ee5d-4ea6-98e7-b03de2f5eb57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stronghold SMS Isolation Gown (AAMI Level 2)-L |
| Version Model Number | SC210L |
| Company DUNS | 080344373 |
| Company Name | The Stronghold Group 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850037694754 [Primary] |
| GS1 | 00850037694808 [Package] Contains: 00850037694754 Package: Carton [10 Units] In Commercial Distribution |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-28 |
| Device Publish Date | 2022-03-19 |
| 10850037694645 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-S | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694693 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-M | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694709 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-L | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694716 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694723 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694785 - Stronghold SMS Isolation Gown (AAMI Level 2)-S | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694792 - Stronghold SMS Isolation Gown (AAMI Level 2)-M | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |
| 00850037694808 - Stronghold SMS Isolation Gown (AAMI Level 2)-L | 2022-03-28This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. |
| 00850037694808 - Stronghold SMS Isolation Gown (AAMI Level 2)-L | 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids |