FDA.reportPublic FDA data

VaPro Plus Pocket

Primary DI
10610075054050
Brand
VaPro Plus Pocket
Company
HOLLISTER INCORPORATED
Model
71102-30
Device description
Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 10 Fr 8 in, Straight
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152268000VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated2015-09-09GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075054050PackageGS18In Commercial Distribution
00610075054053PrimaryGS10
20610075054057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007505405010610075054050
00610075054053006100750540536100750540530610075054053
2061007505405720610075054057

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length8Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
00610075040070InstaFlo330162016-09-21
00610075052332Apogee HC908102016-09-21
00610075052349Apogee HC910062016-09-21
00610075052356Apogee HC910102016-09-21
00610075052363Apogee HC912062016-09-21
00610075052370Apogee HC912162016-09-21
00610075052387Apogee HC914062016-09-21
00610075052394Apogee HC914162016-09-21
00610075052400Apogee HC916162016-09-21
00610075052417Apogee HC918162016-09-21
00610075052424Apogee HC912262016-09-21
00610075052431Apogee HC914262016-09-21
00610075052448Apogee HC916262016-09-21
10610075117250Premier89005890052022-12-01
10610075198631New Image19503195032022-12-01
00610075198443Adapt7730US2018-01-01

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