TDOC Air-Charged 7Fr Dual Lumen, Single Sensor Bladder Catheter

GUDID 20627825011123

Urodynamic manometric catheter, non-electronic Urodynamic manometric catheter, non-electronic

Primary Device ID	20627825011123
NIH Device Record Key	af6a4338-f089-41c7-9340-0ee3df7fcde3
Commercial Distribution Status	In Commercial Distribution
Brand Name	TDOC Air-Charged 7Fr Dual Lumen, Single Sensor Bladder Catheter
Version Model Number	CATT3B27
Company DUNS	203383526
Company Name	Laborie Medical Technologies Canada ULC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
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	00627825011129 [Primary]
GS1	10627825011126 [Package] Contains: 00627825011129 Package: [10 Units] In Commercial Distribution
GS1	20627825011123 [Package] Contains: 10627825011126 Package: [10 Units] In Commercial Distribution

FEN	Device, Cystometric, Hydraulic

Steralize Prior To Use	false
Device Is Sterile	true