PUMA-G Pediatric System™ 0010381

GUDID 10850026037200

Ultrasound-guided gastrostomy system catheter

Primary Device ID	10850026037200
NIH Device Record Key	ae60ccfd-8f62-47f9-850a-ce0c5a52f064
Commercial Distribution Status	In Commercial Distribution
Brand Name	PUMA-G Pediatric System™
Version Model Number	0010380
Catalog Number	0010381
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

Device Issuing Agency	Device ID
GS1	00850026037203 [Primary]
GS1	10850026037200 [Package] Contains: 00850026037203 Package: Shipper Box [4 Units] In Commercial Distribution

KGC	Tube, Gastro-Enterostomy

Steralize Prior To Use	false
Device Is Sterile	false

20850026037177	80% Offset External Magnet in Case
10850026037200	Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit