PUMA-G System™ 0010450-0X, 0010460

GUDID 00850026037272

Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter

Coaptech, Inc.

Ultrasound-guided gastrostomy system catheter
Primary Device ID00850026037272
NIH Device Record Key5527350b-9638-4200-8065-fc9268fdcf74
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUMA-G System™
Version Model Number0010450
Catalog Number0010450-0X, 0010460
Company DUNS080322442
Company NameCoaptech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from other magnetic material

Device Identifiers

Device Issuing AgencyDevice ID
GS100850026037272 [Package]
Contains: 10850026037224
Package: Shipper Box [2 Units]
In Commercial Distribution
GS100850026037296 [Package]
Contains: 10850026037224
Package: Shipper Box [4 Units]
In Commercial Distribution
GS100850026037326 [Package]
Contains: 10850026037224
Package: Shipper Box [1 Units]
In Commercial Distribution
GS110850026037224 [Primary]

FDA Product Code

KGCTube, Gastro-Enterostomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-10
Device Publish Date2024-02-13

On-Brand Devices [PUMA-G System™]

10850026037132External Magnet in Case
10850026037187Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037081Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr
00850026037036Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr
00850026037074Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape
00850026037098Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape
00850026037272Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037319Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit and PUSH P
00860312001542External Magnet in Case
10850026037330Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit
00860312001504Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037227Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
10860312001556Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire
10850026037231Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire with Pull Feature
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.