| Primary Device ID | 06950471300045 |
| NIH Device Record Key | b9ca3aa4-ac72-4864-ad53-f949a37f24b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXAMINATION GOWN |
| Version Model Number | 28021 |
| Company DUNS | 547874292 |
| Company Name | Hangzhou A-Tek Medical & Textiles Co., Ltd. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 06950471300137 - DISPOSABLE HOT OR COLD PACK COVER | 2023-07-31 DISPOSABLE HOT OR COLD PACK COVER, USED TO COVER THE ICE PACK OR HOT PACK |
| 06950471300144 - VACUUM COLLECTION BOTTLE | 2023-07-31 VACUUM COLLECTION BOTTLE, COLLECT LARGER VOLUMES OF FLUID FROM PROCEDURES |
| 06950471300151 - GAS COLLECTING VESSEL | 2023-07-31 GAS COLLECTING VESSEL, COLLECT AND STORE GAS SAMPLES OR LOW PRESSURE GAS STREAMS |
| 06950471300038 - DISPOSABLE BEDDING PRODUCTS | 2023-07-26 MEDICAL DISPOSABLE BEDDING, PROTECT BEDDING FROM GETTING STAINED DURING USE, PROTECT PATIENT FROM CROSS-INFECTION CAUSED BY BEDD |
| 06950471300045 - EXAMINATION GOWN | 2023-07-26EXAMINATION GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS |
| 06950471300045 - EXAMINATION GOWN | 2023-07-26 EXAMINATION GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS |
| 06950471300052 - SURGICAL CAP | 2023-07-26 SURGICAL CAP, HEADWEAR FOR SURGEONS TO WEAR IN OPERATING ROOMS TO PREVENT CONTAMINATION OF THE STERILE AREA |
| 06950471300069 - SURGICAL APPAREL ACCESSORY | 2023-07-26 SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY I |
| 06950471300076 - OPERATING-ROOM SHOE COVER | 2023-07-26 OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR |