| Primary Device ID | M84933040 |
| NIH Device Record Key | d48e3c4e-cc8e-43dc-82ed-fe7aaa71c56c |
| Commercial Distribution Discontinuation | 2025-12-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Hobbs Achalasia Dilation Balloon |
| Version Model Number | 3304 |
| Catalog Number | 3304 |
| Company DUNS | 076769355 |
| Company Name | HOBBS MEDICAL, 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 | 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 |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M84933040 [Primary] |
| KNQ | Dilator, Esophageal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2016-09-21 |
| M84933060 | A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestina |
| M84933040 | A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestina |
| M84933020 | A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestina |