| Primary Device ID | 10817415020595 |
| NIH Device Record Key | 9b78f126-0eb9-4e8f-8e57-442fd7bfc349 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dealmed Isolation Gown |
| Version Model Number | 782045 |
| Company DUNS | 068586441 |
| Company Name | DEALMED MEDICAL SUPPLIES LLC |
| Device Count | 10 |
| DM Exempt | true |
| 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 | 00817415020598 [Primary] |
| GS1 | 10817415020595 [Package] Contains: 00817415020598 Package: CASE [5 Units] In Commercial Distribution |
| GS1 | 18174150205987 [Unit of Use] |
| 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 | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
| 10817415020083 - Dealmed | 2022-09-06 Instant Cold Pack, 6" x 8", Ea |
| 10817415022230 - Dealmed | 2022-09-06 COHESIVE BANDAGE 3" x 5 yards 24/BX 6/Cs |
| 10817415022247 - Dealmed | 2022-09-06 Cohesive Bandage Latex Tan 2 x 5 yds 36/Bx |
| 10817415022254 - Dealmed | 2022-09-06 18" x 26" Fenestrated Drape Ea |
| 10817415022261 - Dealmed | 2022-09-06 18" x 26" Non Fenestrated Drape Ea |
| 10817415022377 - Dealmed | 2022-09-06 STOCKINETTES, 25 YDS x 2" Ea |
| 10817415022384 - Dealmed | 2022-09-06 STOCKINETTES, 25 YDS x 3" Ea |
| 10817415022391 - Dealmed | 2022-09-06 STOCKINETTES, 25 YDS x 4" Ea |