| Primary Device ID | 00850026037098 |
| NIH Device Record Key | 3a0641e6-5774-42e4-b47a-9d8ce06cd59c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PUMA-G System™ |
| Version Model Number | 0010204 |
| Catalog Number | 0010212 |
| Company DUNS | 080322442 |
| Company Name | Coaptech, 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 | true |
| 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 | 00850026037029 [Primary] |
| GS1 | 00850026037098 [Package] Contains: 00850026037029 Package: Shipper Box [2 Units] In Commercial Distribution |
| KGC | Tube, Gastro-Enterostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-25 |
| Device Publish Date | 2023-12-15 |
| 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 |