VaPro Plus

GUDID 00610075080649

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

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter
Primary Device ID00610075080649
NIH Device Record Key4c848a32-d38f-4a35-816a-4729c4b1d46f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaPro Plus
Version Model Number7700144
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

Catheter Gauge14 French
Length16 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100610075061334 [Primary]
GS100610075080649 [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 Plus]

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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
10610075092762No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
10610075092755No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
10610075092748No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
10610075092731No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
10610075092724No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
10610075092717No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti

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