ActiveCare A502B-0002-01

GUDID 07290016525397

MEDICAL COMPRESSION SYSTEM (D.B.N.) LTD.

Sequential venous compression system pump

• Primary Device ID: 07290016525397
• NIH Device Record Key: c5731ef9-eaa7-4b4c-8489-68270a6dd274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiveCare
• Version Model Number: HomeCare ActiveCare+S.F.T
• Catalog Number: A502B-0002-01
• Company DUNS: 531857886
• Company Name: MEDICAL COMPRESSION SYSTEM (D.B.N.) LTD.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com
• Phone: 1-(800)-377-5804
• Email: CustomerService@mcsmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 87 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016525397 [Direct Marking]
GS1	17290016525394 [Primary]
GS1	27290016525391 [Package]; Contains: 17290016525394; Package: [6 Units]; In Commercial Distribution
GS1	37290016525398 [Package]; Contains: 17290016525394; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060146

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-04

On-Brand Devices [ActiveCare]

• 27290016525513: ActiveCare Foot sleeve Pair
• 27290016525506: ActiveCare Thigh sleeve Large Pair
• 27290016525490: ActiveCare Thigh sleeve Medium Pair
• 27290016525483: ActiveCare Thigh sleeve small Pair
• 27290016525476: ActiveCare calf sleeve+stock X-Large pair
• 27290016525469: ActiveCare calf sleeve X-Large pair
• 27290016525452: ActiveCare calf sleeve+stock Large pair
• 27290016525445: ActiveCare calf sleeve Large pair
• 27290016525438: ActiveCare calf sleeve+stock Medium pair
• 27290016525421: ActiveCare calf sleeve Medium pair
• 27290016525414: ActiveCare calf sleeve+stock Small Pair
• 17290016525400: ActiveCare calf sleeve Small Pair
• 07290016525397: HomeCare ActiveCare+S.F.T
• 07290016525380: ActiveCare+S.F.T
• 07290016525373: ActiveCare DVT