VaPro Pocket

GUDID 00610075068760

No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter
Primary Device ID00610075068760
NIH Device Record Keybba1f7ab-68a2-40a9-be43-50053fd8b4e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaPro Pocket
Version Model Number70084-30
Company DUNS005527098
Company NameHOLLISTER INCORPORATED
Device Count30
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-4060
Emailcs@hollister.com

Device Dimensions

Length16 Inch
Catheter Gauge8 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100610075068692 [Primary]
GS100610075068760 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCATHETER, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-10
Device Publish Date2022-09-30

On-Brand Devices [VaPro Pocket]

00610075067985No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075067978No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075067893No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075067787No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075068760No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075087754No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075087730No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
00610075072378No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
20610075090796No Touch Urethral Intermittent Catheter, Hydrophilic, Coude Tip, Protective Tip and Sleeve
20610075090789No Touch Urethral Intermittent Catheter, Hydrophilic, Coude Tip, Protective Tip and Sleeve
10610075093080No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075093073No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075093066No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075093059No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075092991No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075092984No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075092977No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
10610075092960No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.