FDA.reportPublic FDA data

PUMA-G System™

Primary DI
00850026037029
Brand
PUMA-G System™
Company
Coaptech, Inc.
Model
0010204
Catalog number
0010212
Device description
Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Safety PUSH PEG Kit)
Published
2023-12-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850026037098PackageGS12Not in Commercial Distribution
00850026037029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026037098008500260370988500260370980850026037098
00850026037029008500260370298500260370290850026037029

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.

Contacts#

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

Regulatory Flags#

DUNS number
080322442
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860312001532PUMA-G System™001008000100902024-05-16
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
00850026037272PUMA-G System™00104500010450-0X, 00104602024-02-13

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
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
00850026037081PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037187PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037132PUMA-G System™Coaptech, Inc.KGC2023-07-13