circuitGuard® ThermoFlo®
GUDID 10810050852217
circuitGuard® ThermoFlo® 1 Filter – Combined Heat Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow
TYPENEX MEDICAL LLC
Heat/moisture exchanger/microbial filter, non-sterile| Primary Device ID | 10810050852217 |
| NIH Device Record Key | 92a7ca13-50b1-4846-a0e3-1a9fb40624db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | circuitGuard® ThermoFlo® |
| Version Model Number | 6126 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050852210 [Primary] |
| GS1 | 10810050852217 [Package] Contains: 00810050852210 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
| 00810050855648 - Rad Control | 2024-07-23 25 Gy Universal Irradiation Tag (RT0301XVT) |
| 26941850890275 - Anesthesia Breathing Circuit Kit | 2024-05-16 Adult Anesthesia Breathing Circuit Kit - 90" Dual Limb Breathing Circuit - Bacterial Viral Filter - Size 5 Anesthesia Mask - 3L |
| 00810050855488 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Blue |
| 00810050855501 - Tourniquets | 2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Blue |
| 00810050855525 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Orange |
| 00810050855549 - Tourniquets | 2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Orange |
| 00810050855563 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Flat, Blue |
| 00810050855587 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Flat, Orange |
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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