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 Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover 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]