Primary Device ID | 00381342000799 |
NIH Device Record Key | b70cc96e-bdfe-43ad-9e1c-08ded9fa8309 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Health Supply US Level 2 Gown |
Version Model Number | HSUS-L2-EC-M |
Catalog Number | HSUS-L2-EC-M |
Company DUNS | 117465816 |
Company Name | Health Supply US, LLC |
Device Count | 10 |
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 | false |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00381342000584 [Primary] |
GS1 | 00381342000782 [Unit of Use] |
GS1 | 00381342000799 [Package] Contains: 00381342000584 Package: Case [10 Units] In Commercial Distribution |
GS1 | 00381342000805 [Package] Package: Pallet [12 Units] In Commercial Distribution |
OEA | Non-Surgical 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 | 2024-06-26 |
Device Publish Date | 2024-06-18 |
00381342000768 | Pack of 10 L2 SMS non-sterile Isolation Gowns |
00381342000799 | Pack of 10 Level 2 non-sterile isolation gown |
00381342000829 | Pack of 10 Level 2 SMS non-sterile isolation gowns |
00381342000744 | Pack of 10 Level 2 non-sterile, single-use, isolation gowns - gowns are not sold individually |
00381342000751 | Package of 10 single-use, non-sterile L2 SMS isolation gowns - gowns are not sold individually. |