VaPro Plus

GUDID 00610075176144

No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Tip, Protective Tip and Sleeve

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter
Primary Device ID00610075176144
NIH Device Record Key15f3962b-0c16-41e3-9779-9abe006b2343
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaPro Plus
Version Model Number74144-30
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
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com

Device Dimensions

Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100610075065578 [Unit of Use]
GS100610075176144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCATHETER, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2022-10-06
Device Publish Date2016-09-21

On-Brand Devices [VaPro Plus]

10610075176219Ready to Use Hydrophilic Closed System Intermittent Catheter, 14 Fr 8 in, Straight
10610075176202Ready to Use Hydrophilic Closed System Intermittent Catheter, 12 Fr 8 in, Straight
10610075176141Ready to Use Hydrophilic Closed System Intermittent Catheter, 14 Fr 16 in, Straight
10610075176134Ready to Use Hydrophilic Closed System Intermittent Catheter, 12 Fr 16 in, Straight
00610075176212No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
00610075176205No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
00610075176144No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
00610075176137No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
00610075080649No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
00610075080632No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti

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