Cirona

GUDID 10879766005294

DVT Large calf garment

OAKWELL DISTRIBUTION, INC.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 10879766005294
• NIH Device Record Key: 409faeb0-6e6a-437d-a4cd-1f7f7d4b050a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cirona
• Version Model Number: D-120
• Company DUNS: 033337813
• Company Name: OAKWELL DISTRIBUTION, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879766005297 [Primary]
GS1	10879766005294 [Package]; Contains: 00879766005297; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141578

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-30

On-Brand Devices [Cirona]

• 20879766005444: Deep Vein Thrombosis Prevention Therapy
• 10879766005430: Deep Vein Thrombosis (DVT) Prevention THerapy
• 10879766005423: Deep Vein Thrombosis (DVT) Prevention Therapy
• 10879766005348: DVT Extra large thigh garment
• 10879766005331: DVT Large thigh garment
• 10879766005324: DVT Small thigh garment
• 10879766005317: DVT Extra large calf garment
• 10879766005300: DVT Extra large calf garment
• 10879766005294: DVT Large calf garment
• 10879766005287: DVT Standard calf garment
• 10879766005270: Small foot garment
• 10879766005263: Standard Foot garment