| Primary Device ID | 10850026037231 |
| NIH Device Record Key | 76db02fc-93b9-46fa-ab48-15b20a776b0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PUMA-G System™ |
| Version Model Number | 0010416 |
| Catalog Number | 0010470 |
| Company DUNS | 080322442 |
| Company Name | Coaptech, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com | |
| Phone | 1 443 574 6934 |
| info@coaptech.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850026037210 [Package] Package: Shipper Box [2 Units] In Commercial Distribution |
| GS1 | 00850026037234 [Primary] |
| GS1 | 10850026037231 [Package] Contains: 00850026037234 Package: Carton [2 Units] In Commercial Distribution |
| KGC | Tube, Gastro-Enterostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
| 10850026037132 | External Magnet in Case |
| 10850026037187 | Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter |
| 00850026037081 | Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr |
| 00850026037036 | Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr |
| 00850026037074 | Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape |
| 00850026037098 | Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape |
| 00850026037272 | Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter |
| 00850026037319 | Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit and PUSH P |
| 00860312001542 | External Magnet in Case |
| 10850026037330 | Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit |
| 00860312001504 | Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter |
| 00850026037227 | Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter |
| 10860312001556 | Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire |
| 10850026037231 | Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire with Pull Feature |