PUMA-G System™ 0010366

GUDID 10850026037132

External Magnet in Case

Coaptech, Inc.

Ultrasound-guided gastrostomy system magnet
Primary Device ID10850026037132
NIH Device Record Key6827d857-f6a1-4581-98f5-9a0447625099
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUMA-G System™
Version Model Number0010323
Catalog Number0010366
Company DUNS080322442
Company NameCoaptech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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 ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from ferromagnetic material

Device Identifiers

Device Issuing AgencyDevice ID
GS100850026037135 [Direct Marking]
GS100850026037142 [Package]
Package: Shipper Box [1 Units]
In Commercial Distribution
GS110850026037132 [Primary]

FDA Product Code

KGCTube, Gastro-Enterostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-13
Device Publish Date2023-07-13

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
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