CoreTech

GUDID 10810113572694

BT Pump Replacement Leg Sleeve (Small)

VIVE HEALTH LLC

Single-chamber venous compression system garment, reusable

• Primary Device ID: 10810113572694
• NIH Device Record Key: 0979ac23-9f59-4cbc-b767-fc20527496cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreTech
• Version Model Number: RHB2086SLES
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113572697 [Primary]
GS1	10810113572694 [Package]; Contains: 00810113572697; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201982

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [CoreTech]

• 10810041987881: 916 Wrist Brace
• 10810041987294: DVT Pump
• 10850041211005: 670 Universal Arm Sling
• 10810041982343: 456 TLSO
• 10810041986204: Large Standard Back Brace (Black)
• 10810041986198: Standard Back Brace (Black)
• 10850041211807: 960 Arm Sling (Black)
• 10810041987003: Standard Pneumatic Walker Black (XS)
• 10810041980363: Standard Pneumatic Walker Black (XL)
• 10810041980356: Standard Pneumatic Walker Black (Large)
• 10810041980349: Standard Pneumatic Walker Black (Medium)
• 10810041980332: Standard Pneumatic Walker Black (Small)
• 10810041987010: Short Pneumatic Walker (Black) (XS)
• 10810041980998: Short Pneumatic Walking Boot (Black) (Medium)
• 10810041980608: Tall Pneumatic Walking Boot (Black) (XL)
• 10810041980578: Tall Pneumatic Walking Boot (Black) (Large)
• 10810041980523: Tall Pneumatic Walking Boot (Black) (Medium)
• 10810041980516: Short Pneumatic Walking Boot (Black) (XL)
• 10810041980509: Short Pneumatic Walking Boot (Black) (Large)
• 10810041980479: Tall Pneumatic Walking Boot (Black) (Small)
• 10810041980462: Short Pneumatic Walking Boot (Black) (Small)
• 10810041980400: Short Pneumatic Walker (Black) (XL)
• 10810041980394: Short Pneumatic Walker (Black) (Large)
• 10810041980387: Short Pneumatic Walker (Black) (Medium)
• 10810041980370: Short Pneumatic Walker (Black) (Small)
• 10810113570607: Short Pneumatic Walking Boot (Black) XS
• 10810113570591: Tall Pneumatic Walking Boot (Black) XS
• 10810041986914: 4386 Short Walker Boot (XS)
• 10810041986907: 4386 Standard Walker Boot (XS)
• 10810041980745: 4386 Short Walker Boot (XL)
• 10810041980714: 4386 Short Walker Boot (Large)
• 10810041980684: 4386 Short Walker Boot (Medium)
• 10810041980653: 4386 Short Walker Boot (Small)
• 10810041980615: 4386 Standard Walker Boot (XL)
• 10810041980554: 4386 Standard Walker Boot (Large)
• 10810041980493: 4386 Standard Walker Boot (Medium)
• 10810041980486: 4386 Standard Walker Boot (Small)
• 10850041211975: 1830 Tri-Panel Knee Immobiliser 10"
• 10810041981933: 1906 Motion Ankle Brace (Black) (Right) Large
• 10810041981926: 1906 Motion Ankle Brace (Black) (Right) Medium
• 10810041981919: 1906 Motion Ankle Brace (Black) (Right) Small
• 10810041981902: 1096 Motion Ankle Brace (Black) (Right) XS
• 10810041981896: 1906 Motion Ankle Brace (Black) (Left) Large
• 10810041981889: 1906 Motion Ankle Brace (Black) (Left) Medium
• 10810041981872: 1906 Motion Ankle Brace (Black) (Left) Small
• 10810041981865: 906 Motion Ankle Brace (Black) (Left) XS
• 10810041980967: 1830 Tri-Panel Knee Immobiliser 24"
• 10810041980950: 1830 Tri-Panel Knee Immobiliser 22"
• 10810041980936: 1830 Tri-Panel Knee Immobiliser 20"
• 10810041980929: 1830 Tri-Panel Knee Immobiliser 18"