| Primary Device ID | 00813307012085 |
| NIH Device Record Key | 53633d6b-101c-4e5f-9d92-1db96859f707 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InHealth Technologies; Blom-Singer |
| Version Model Number | BE 6398 |
| Company DUNS | 120981337 |
| Company Name | Freudenberg Medical, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com | |
| Phone | 800-477-5969 |
| InHealth@inhealth.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813307012085 [Primary] |
| KAC | Tube, Laryngectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-01 |