| Primary Device ID | 00850078013002 |
| NIH Device Record Key | 159d2244-2fdb-4eef-b1a5-8642f4314939 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXAIR |
| Version Model Number | 2281PRS-100 |
| Catalog Number | 2281PRS-100 |
| Company DUNS | 078715452 |
| Company Name | Syntech, Int'l Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078013002 [Primary] |
| GS1 | 10850078013009 [Package] Package: [20 Units] In Commercial Distribution |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
[00850078013002]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-22 |
| Device Publish Date | 2026-01-14 |