Game Ready

GUDID 00812120000972

Amputee, Above Knee Sleeve, Left

GAME READY DIVISION

Circulating-fluid thermal/compression therapy system wrap

• Primary Device ID: 00812120000972
• NIH Device Record Key: 8d64fd53-fe4d-453d-8b86-b527c9fecaf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Game Ready
• Version Model Number: 510916
• Company DUNS: 840831411
• Company Name: GAME READY DIVISION
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812120000972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072620

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

On-Brand Devices [Game Ready]

• 00812120003140: Full Leg Boot Wrap ( Medium).
• 00812120003119: ATX, Heat Exchanger, Full Leg Boot, Medium
• 00812120003102: ATX, Heat Exchanger, Full Leg Boot, Large
• 00812120003096: ATX, Heat Exchanger, Full Leg Boot, Extra Large
• 00812120003089: Sleeve, Full Leg Boot, Medium
• 00812120003072: Sleeve, Full Leg Boot, Large
• 00812120003065: Sleeve, Full Leg Boot, Extra Large
• 00812120003027: Battery Pack, Lithium Ion
• 00812120002969: Power Cord, GRPro 2.1, Brazil
• 00812120002266: Rechargeable Lithium Ion Battery Pack Connector Cable
• 00812120002204: Rechargeable Lithium Ion Battery Pack Kit
• 00812120001948: Cryo Cap Sleeve
• 00812120001931: Amputee Sleeve, Utility
• 00812120001924: Amputee, Above Knee Sleeve, Left
• 00812120001917: Amputee, Above Knee Sleeve, Right
• 00812120001900: Traumatic Amputee Sleeve, below Knee, Large
• 00812120001894: Half Leg Boot Sleeve
• 00812120001887: Flexed Elbow Sleeve
• 00812120001870: Hand/Wrist Sleeve
• 00812120001863: Left Hip/Groin Sleeve
• 00812120001856: Right Hip/Groin Sleeve
• 00812120001849: C-T Spine Sleeve, LRG
• 00812120001832: Back Sleeve
• 00812120001825: Left Shoulder Sleeve - Large
• 00812120001818: Right Shoulder Sleeve - Large
• 00812120001801: Left Shoulder Sleeve - Medium
• 00812120001795: Right Shoulder Sleeve - Medium
• 00812120001788: Ankle Sleeve - Extra Large
• 00812120001771: Ankle Sleeve - Large
• 00812120001764: Elbow Sleeve
• 00812120001757: Articulated Knee Wrap Disposable Cover (CPM Compatible)
• 00812120001740: Straight Knee Sleeve
• 00812120001528: ATX, Wrap, Cooling Vest
• 00812120001511: ATX, Heat Exchanger, Cooling Vest
• 00812120001382: Game Ready System, GR Pro 2.1, Brazil Medical
• 00812120001375: Game Ready System, GR Pro 2.1, Brazil
• 00812120001368: Game Ready System, GR Pro 2.1, OUS Medical
• 00812120001351: Game Ready System, GR Pro 2.1, Medical
• 00812120001344: Wrap Extender Strap Kit
• 00812120001337: Wrap Extender Strap, 8"
• 00812120001320: Wrap Extender Strap, 18"
• 00812120001313: Power Supply, GRPro 2.1, class II
• 00812120001306: Power Cord, Australia 2-Pole, AS-NZS 4417 x IEC 60320 C7, 2m, BLK
• 00812120001290: Power Cord, China 2-Pole, GB 15934-2008 x IEC 60320 C7, 2m, BLK
• 00812120001283: Power Cord, UK 2-Pole, BS 1363 UK3 x IEC 60320 C2, 2m, BLK
• 00812120001276: Power Cord, US 2-Pole, NEMA 1-15P x IEC 60320 C7, 2m, BLK
• 00812120001269: Strap, Chin, Cryo Cap
• 00812120001252: Cryo Cap Heat Exchanger
• 00812120001245: Cryo Cap Sleeve
• 00812120001238: Cryo Cap Wrap