Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]

GUDID 20376885022012

Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]

Emergency Medical Solutions LLC

Shoe cover

• Primary Device ID: 20376885022012
• NIH Device Record Key: 43f4c019-695a-47e2-a144-2445399acbe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]
• Version Model Number: EMS-11411
• Company DUNS: 117478411
• Company Name: Emergency Medical Solutions LLC
• Device Count: 440
• 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	00376885022018 [Unit of Use]
GS1	20376885022012 [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

Devices Manufactured by Emergency Medical Solutions LLC

• 20376885018015 - Knee high boot covers (45g SMS): 2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B]
• 20376885019012 - Knee high boot covers (45g SMS): 2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms (welded), Tie to tighten boat) [EMS-11222]
• 20376885020018 - Knee high boot covers (45g SMS): 2021-05-20 knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211]
• 20376885021015 - Knee high boot cover (40g SMS): 2021-05-20 Knee high boot cover (40g SMS + pvc non slip) [EMS-11311]
• 20376885022012 - Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]: 2021-05-20Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]
• 20376885022012 - Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]: 2021-05-20 Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]
• 20376885023019 - Shoe cover (35gsm PP half elastic) [EMS-10221]: 2021-05-20 Shoe cover (35gsm PP half elastic) [EMS-10221]
• 20376885024016 - Shoe cover (33gsm PP full elastic) [EMS-10211]: 2021-05-20
• 20376885025013 - Shoe cover (40gsm PP half elastic) [EMS-10232]: 2021-05-20 Shoe cover (40gsm PP half elastic) [EMS-10232]