zhende

GUDID 00850006820252

Zhende AAMI3 Surgical Gown with Reinforcement, 45g/m2 SMS, Level 3, AAMI3,FDA registered, 28 packs, SIZE M

Boston Bgecare Inc

Surgical gown, single-use

• Primary Device ID: 00850006820252
• NIH Device Record Key: bad1dcef-f364-4415-b0a5-57506e269d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: zhende
• Company DUNS: 056757726
• Company Name: Boston Bgecare 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006820252 [Primary]

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-27
• Device Publish Date: 2023-11-19

On-Brand Devices [zhende]

• 00850006820252: Zhende AAMI3 Surgical Gown with Reinforcement, 45g/m2 SMS, Level 3, AAMI3,FDA registered, 28 pa
• 00850006820061: Zhende Disposable face mask,Blue,Narrow Spandex Ear Loops, pack of 50pcs, 2 packs, 100pcs