PUMA-G System™ 0010445-04

GUDID 10850026037330

Ultrasound-guided gastrostomy system catheter

Primary Device ID	10850026037330
NIH Device Record Key	74e1461f-3791-4e62-9e52-b7ebdd6a94e1
Commercial Distribution Status	In Commercial Distribution
Brand Name	PUMA-G System™
Version Model Number	0010445
Catalog Number	0010445-04
Company DUNS	080322442
Company Name	Coaptech, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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

Device Issuing Agency	Device ID
GS1	00850026037333 [Primary]
GS1	10850026037330 [Package] Contains: 00850026037333 Package: Shipper Box [4 Units] In Commercial Distribution

KGC	Tube, Gastro-Enterostomy

Steralize Prior To Use	false
Device Is Sterile	true

10850026037132	External Magnet in Case
10850026037187	Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037081	Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr
00850026037036	Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr
00850026037074	Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape
00850026037098	Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape
00850026037272	Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037319	Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit and PUSH P
00860312001542	External Magnet in Case
10850026037330	Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit
00860312001504	Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037227	Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
10860312001556	Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire
10850026037231	Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire with Pull Feature