| Primary Device ID | 00854427007995 |
| NIH Device Record Key | 6e6bb0ef-541c-441f-b98a-b2beb5be4c5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEPRO.US Lab Suit 1 Pouch |
| Version Model Number | Single Pouch Lab Suit |
| Company DUNS | 080061451 |
| Company Name | HEPRO.US INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| 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 | 00854427007995 [Primary] |
| FXO | Suit, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-20 |
| 00850578007228 - HEPRO.US - Blood Collection set with pre-attached holder 23Gx3/4"x12" Pack | 2019-10-23 Blood Collection SET with pre-attached holder 23G x 3/4" x 12" PE package 50pcs |
| 00850578007600 - HEPRO.US Blood Collection Sets with Pre-Attached Holder | 2019-10-23 Blood Collection Sets with Pre-Attached Holder Single 23G x 3/4 x 12" |
| 00850578007617 - Hepro.us - Case of 10 Boxes of Blood collection sets with pre-attached hold | 2019-10-23 Case of 10 Boxes of Blood collection sets with pre-attached holder |
| 00854427007018 - HEPRO.US - Needle Pen Tip 1 Box 100pcs | 2019-10-23 Insulin Pen Needle Sterile Single Use Pen Needle 31G 0.25x 6m. Fits most Insulin Pens 100pcs per 1 Box |
| 00854427007056 - HEPRO.US Standard Surgical Gown Case | 2019-10-23 Material 68gsm A/S Spunlace Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 40 Sterile Pouch |
| 00854427007063 - HEPRO.US Reinforced Surgical Gown Case 43gsm | 2019-10-23 Material 43gsm A/S SMMS Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 50 Sterile Pouch - Case |
| 00854427007841 - HEPRO.US Standard Surgical Gown L 43gsm 1 Pouch | 2019-10-23 Standard Surgical Gown L 1 Pouch 43gsm A/S SMMS, with two hand paper towels and wrapper, EO Sterile |
| 00854427007858 - HEPRO.US Reinforced Surgical Gown L 43gsm | 2019-10-23 Reinforced Surgical Gown L 1 Pouch 43gsm SMMS |