Knee high boot covers (45g SMS)

GUDID 20376885018015

knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B]

Emergency Medical Solutions LLC

Shoe cover

• Primary Device ID: 20376885018015
• NIH Device Record Key: a02bbb80-93eb-4bff-b899-0904227bd6cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knee high boot covers (45g SMS)
• Version Model Number: EMS-11211B
• Company DUNS: 117478411
• Company Name: Emergency Medical Solutions LLC
• Device Count: 400
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00376885018011 [Unit of Use]
GS1	20376885018015 [Primary]

FDA Product Code

• FXP: Cover, Shoe, Operating-Room

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: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [ Knee high boot covers (45g SMS)]

• 20376885020018: knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211]
• 20376885019012: knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms (welded), Tie to tighten b
• 20376885018015: knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-1