1MED

GUDID 10850027748846

1MED Disposable Surgical Gown, Large, sterile

Qyk Brands LLC

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use

• Primary Device ID: 10850027748846
• NIH Device Record Key: fcab7162-2c6f-48d5-9a5d-3400795a3fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1MED
• Version Model Number: SRGL3-FBTN-1R
• Company DUNS: 081560441
• Company Name: Qyk Brands LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850027748846 [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: 2022-05-09
• Device Publish Date: 2022-05-01

On-Brand Devices [1MED]

• 10850027748846: 1MED Disposable Surgical Gown, Large, sterile
• 00850039859496: 1MED Surgical Mask, Level 1, Earloop style non-sterile, single-use, 50ct Box
• 00850039859472: 1MED Surgical Mask, Level 3, Earloop style non-sterile, single-use, 50ct Box
• 00850039859489: 1MED Surgical Mask, Level 2, Earloop style non-sterile, single-use, 50ct Box