Cystosure

GUDID 00866403000210

Indwelling urethral drainage catheter

Primary Device ID	00866403000210
NIH Device Record Key	4e3f071c-330a-4b3b-ac4e-3cad6dad2b75
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cystosure
Version Model Number	10-400
Company DUNS	052321836
Company Name	EMMY MEDICAL LLC
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	false
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00866403000210 [Primary]
GS1	10866403000217 [Package] Package: Shelf Box [5 Units] In Commercial Distribution
GS1	20866403000214 [Package] Contains: 10866403000217 Package: Shipping Carton [40 Units] In Commercial Distribution

EZL	Catheter, Retention Type, Balloon

Steralize Prior To Use	false
Device Is Sterile	true

00866403000265	Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long
00866403000234	Scope, 70 deg, 2.7 mm, long (270mm)
00866403000210	16Fr Cystosure Plus, 16Fr, silicone catheter
00866403000203	Cystosure XL, 16 Fr, silicone catheter

Mark Image Registration \| Serial	Company Trademark Application Date
CYSTOSURE 86147836 4701068 Live/Registered	Emmy Medical, LLC 2013-12-19