NON-SURGICAL ISOLATION GOWN

GUDID 06950471300106

NON-SURGICAL ISOLATION GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL

Hangzhou A-Tek Medical & Textiles Co., Ltd.

Isolation gown, single-use

• Primary Device ID: 06950471300106
• NIH Device Record Key: bbae322a-35ae-4da9-9e31-e9941c1e6ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NON-SURGICAL ISOLATION GOWN
• Version Model Number: 28027
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950471300106 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-26
• Device Publish Date: 2023-07-18

Devices Manufactured by Hangzhou A-Tek Medical & Textiles Co., Ltd.

• 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: 2023-07-26 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