CoreTech

GUDID 10810113571925

BT Lymphedema Pump (PCD) Small

VIVE HEALTH LLC

Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system

• Primary Device ID: 10810113571925
• NIH Device Record Key: 875af1cd-cc9d-4b92-9b69-3924efae3651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreTech
• Version Model Number: RHB2086BLKS
• 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	00810113571928 [Primary]
GS1	10810113571925 [Package]; Contains: 00810113571928; Package: Case [12 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: 2023-07-14
• Device Publish Date: 2023-07-06

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"