FDA.reportPublic FDA data

PUMA-G System™

Primary DI
00850026037081
Brand
PUMA-G System™
Company
Coaptech, Inc.
Model
0010210
Catalog number
0010218
Device description
Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Drape and Standard PUSH PEG Kit)
Published
2023-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGCTube, Gastro-Enterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGCTube, Gastro-EnterostomyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026037081PackageGS12In Commercial Distribution
00850026037043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026037081008500260370818500260370810850026037081
00850026037043008500260370438500260370430850026037043

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound-guided gastrostomy system catheterA sterile, flexible, tubular device with an inflatable balloon and a magnet at its distal end intended to be placed in the stomach, via the oesophagus, and used to move the stomach to the anterior abdominal wall via attraction by an external magnet (not included), to facilitate a gastrostomy. The balloon is filled with a fluid (e.g., saline) to enable detection by an ultrasound imaging system (not included) for its optimal placement without intervention of other anatomical structures (e.g., organs, vessels). Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 443 574 6934info@coaptech.com

Regulatory Flags#

DUNS number
080322442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860312001532PUMA-G System™001008000100902024-05-16
00850026037029PUMA-G System™001020400102122023-12-15
00850026037043PUMA-G System™001021000102182023-07-13
00850026037050PUMA-G System™001020800102162023-12-15
00860312001504PUMA-G System™001004000103592023-07-13
00850026037036PUMA-G System™001020600102142023-07-13
10850026037170PUMA-G Pediatric System™001040000104052025-12-23
00850026037203PUMA-G Pediatric System™001038000103812025-12-23
10850026037200PUMA-G Pediatric System™001038000103812025-12-23
20850026037177PUMA-G Pediatric System™001040000104052025-12-23
00850026037234PUMA-G System™001041600104702024-10-29
00860312001559PUMA-G System™001004600101702024-10-29
10850026037231PUMA-G System™001041600104702024-10-29
10860312001556PUMA-G System™001004600101702024-10-29
00850026037227PUMA-G System™00104400010450-0X, 00104602024-02-13
00850026037333PUMA-G System™00104450010445-042024-05-16
10850026037330PUMA-G System™00104450010445-042024-05-16
00860312001542PUMA-G System™001008000100902024-05-16
00850026037319PUMA-G System™001048000104802024-05-09
10850026037132PUMA-G System™001032300103662023-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850026037170PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00850026037203PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
10850026037200PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
20850026037177PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00842071148935GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-04-07
00842071148973GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071149000GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071147297GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-11-27
00850026037234PUMA-G System™Coaptech, Inc.KGC2024-10-29
00860312001559PUMA-G System™Coaptech, Inc.KGC2024-10-29
10850026037231PUMA-G System™Coaptech, Inc.KGC2024-10-29
10860312001556PUMA-G System™Coaptech, Inc.KGC2024-10-29
00842071144968GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
00842071144999GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
10860312001532PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037333PUMA-G System™Coaptech, Inc.KGC2024-05-16
10850026037330PUMA-G System™Coaptech, Inc.KGC2024-05-16
00860312001542PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037319PUMA-G System™Coaptech, Inc.KGC2024-05-09
00850026037227PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037272PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037029PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037050PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037098PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037074PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037043PUMA-G System™Coaptech, Inc.KGC2023-07-13
00860312001504PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037036PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037187PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037132PUMA-G System™Coaptech, Inc.KGC2023-07-13