PUMA-G Pediatric System
Coaptech, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015177732 | 3015177732 | CoapTech, Inc. | 1 | N | 2026-01-01 | 101 W. Dickman Street, Suite 700 Baltimore MD US 21230 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850026037029 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Safety PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037036 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit without Drape and Safety PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037043 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit without Drape and Standard PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037050 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Standard PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037203 | PUMA-G Pediatric System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemEssentials Kit | 1-443-574-6934 | info@coaptech.com |
| 00860312001504 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemBalloon Catheter | 1 443 574 6934 | info@coaptech.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 222924 | 1168456978 | K242211 | PUMA-G Pediatric System | KGC | 2025-04-29 |
| 222924 | 1808418125 | K223916 | PUMA-G System | KGC | 2023-03-29 |
| 222924 | 2016303327 | K183057 | PUMA-G System | KGC | 2019-04-10 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KGC | 3 | 2025-04-29 |
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2023-07-13
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2023-12-15
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