INOUE BALLOON A

GUDID 14960685201242

Cardiac valvuloplasty catheter

Primary Device ID	14960685201242
NIH Device Record Key	aae2ef76-063f-446a-801a-eb68129a4aa1
Commercial Distribution Status	In Commercial Distribution
Brand Name	INOUE BALLOON A
Version Model Number	PTAV-24R
Company DUNS	690535422
Company Name	TORAY INDUSTRIES,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	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place

Device Issuing Agency	Device ID
GS1	14960685201242 [Primary]

OZT	Balloon Aortic Valvuloplasty

Steralize Prior To Use	false
Device Is Sterile	true