| Primary Device ID | 00816472020435 | 
| NIH Device Record Key | 7ba0d8dd-8e25-40cc-8b2e-6180ed4ad0df | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Filta-Therm™ HMEF with luer port, retainable cap and Flextube™ | 
| Version Model Number | 19416500 | 
| Company DUNS | 785952607 | 
| Company Name | Intersurgical Incorporated | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | MR Safe | 
| 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | |
| Phone | 315-451-2900 | 
| support@intersurgicalinc.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00816472020428 [Primary] | 
| GS1 | 00816472020435 [Package] Contains: 00816472020428 Package: [20 Units] In Commercial Distribution  | 
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2025-02-11 | 
| Device Publish Date | 2023-01-12 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() FILTA-THERM  74065583  1742215 Live/Registered  | 
        INTERSURGICAL LIMITED  1990-06-04  |