circuitGuard® FilterFlo™
GUDID 10810050853689
CircuitGuard ® FilterFlo TM Filter –Bacterial Viral Filter w O2 Port and Elbow
TYPENEX MEDICAL LLC
Heat/moisture exchanger/microbial filter, non-sterile| Primary Device ID | 10810050853689 |
| NIH Device Record Key | c7c44215-85bc-4a41-9618-9b1218a2ef5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | circuitGuard® FilterFlo™ |
| Version Model Number | 7056 |
| Company DUNS | 600850213 |
| Company Name | TYPENEX MEDICAL LLC |
| 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 | 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 |
Customer Support Contacts
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050853682 [Primary] |
| GS1 | 10810050853689 [Package] Contains: 00810050853682 Package: Case [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090738
FDA Product Code
| CAH | Filter, Bacterial, Breathing-Circuit |
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 | 2021-07-29 |
| Device Publish Date | 2021-07-21 |
Devices Manufactured by TYPENEX MEDICAL LLC
| 10810050855782 - Fibernex Laser System | 2025-08-05 Fibernex Go Laser System |
| 20810050855772 - Microscope Slides | 2025-07-22 Liquid Based Cytology Slides, Uncoated, Single Circle, Ground Edge, 45° Corners, Blue (LC0104B) |
| 20810050855765 - Microscope Slides | 2025-07-16 Premium Microscope Slide, Ground Edges, 45° Corners, White (PS0204W) |
| 20810050855741 - Microscope Slides | 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - White Frosted (PS0404WXT) |
| 20810050855758 - Microscope Slides | 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - Yellow Frosted (PS0404YXT) |
| 00810050855457 - Rad Control | 2025-06-02 15 Gy Universal Irradiation Tag |
| 00810050855471 - Rad Control | 2025-06-02 25 Gy Universal Irradiation Tag |
| 20810050855697 - Microscope Sldies | 2025-02-11 Liquid Based Cytology Slides, Single Printed Circle, Ground Edge 45° Corners |
Trademark Results [circuitGuard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CIRCUITGUARD 87707813 5512954 Live/Registered |
ARC Medical Inc. 2017-12-04 |
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