Circul8 C800
GUDID 00850998008027
The Circul8 is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
MANAMED INC
Multi-chamber venous compression system garment, single-use| Primary Device ID | 00850998008027 |
| NIH Device Record Key | aebc4050-0602-4dc8-9ed7-9991ca9c0553 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Circul8 |
| Version Model Number | C800 |
| Catalog Number | C800 |
| Company DUNS | 084042331 |
| Company Name | MANAMED 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 | true |
| 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 |
Customer Support Contacts
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com | |
| Phone | 888-963-6265 |
| info@pmpmed.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850998008027 [Primary] |
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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-02 |
Devices Manufactured by MANAMED INC
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| 00810113681092 - ManaMed Inc | 2024-06-03 Reusable extra large size compression calf garment, increases venous blood flow to help prevent deep vein thrombosis. |
| 00810113683218 - ManaMed | 2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl |
| 00850998008089 - ManaMed | 2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl |
| 00850998008423 - ManaMed | 2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl |
| 00850998008904 - ManaMed | 2024-05-08 The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or aid in the prevention of DVT. T |
| 00810113682655 - ManaMed Inc | 2023-09-05 ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold t |
| 00810113682662 - ManaMed Inc | 2023-09-05 ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold th |
Trademark Results [Circul8]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CIRCUL8 88209137 5787519 Live/Registered |
PRECISION MEDICAL PRODUCTS, INC. 2018-11-28 |
 CIRCUL8 87762355 not registered Dead/Abandoned |
MAS INNOVATION (PRIVATE) LIMITED 2018-01-19 |
 CIRCUL8 79273099 not registered Live/Pending |
Prodigentia Information Technologies S.A. 2019-05-07 |
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