| Primary Device ID | 00842071136598 |
| NIH Device Record Key | b6b61a18-feb3-4490-aa10-d62d4b8e2dbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balloon G-Tube |
| Version Model Number | 7-1810-I |
| Catalog Number | 7-1810-I |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071136598 [Primary] |
| KNT | Tubes, Gastrointestinal (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-16 |
| Device Publish Date | 2024-09-06 |
| 00842071136635 | 24FR Balloon G-Tube with ENFit® Port (Box), MDR |
| 00842071136628 | 24FR Balloon G-Tube (Box), MDR |
| 00842071136611 | 20FR Balloon G-Tube with ENFit® Port (Box), MDR |
| 00842071136604 | 20FR Balloon G-Tube (Box), MDR |
| 00842071136598 | 18FR Balloon G-Tube with ENFit® Port (Box), MDR |
| 00842071136581 | 18FR Balloon G-Tube (Box), MDR |
| 00842071136574 | 16FR Balloon G-Tube with ENFit® Port (Box), MDR |
| 00842071136567 | 16FR Balloon G-Tube (Box), MDR |
| 00842071136550 | 14FR Balloon G-Tube with ENFit® Port (Box), MDR |
| 00842071136543 | 14FR Balloon G-Tube (Box), MDR |
| 00842071136536 | 12FR Balloon G-Tube with ENFit® Port (Box), MDR |
| 00842071136529 | 12FR Balloon G-Tube (Box), MDR |