FDA.reportPublic FDA data

Hollister

Primary DI
00610075055982
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9840
Catalog number
9840
Device description
Female Urinary Pouch, SoftFlex
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOADEVICE, PASTE-ON FOR INCONTINENCE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOADevice, Paste-On For Incontinence, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075055989PackageGS112In Commercial Distribution
00610075055982PrimaryGS10
00610075098408Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007505598910610075055989
00610075055982006100750559826100750559820610075055982
00610075098408006100750984086100750984080610075098408

GMDN Terms#

Term, Definition table
TermDefinition
Female wearable urinal, single-useA non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06
00610075094394VaPro Plus Pocket71102711022024-06-26
00610075094400VaPro Plus Pocket71122711222024-06-26
00610075094424VaPro Plus Pocket71142711422024-06-26
00610075094431VaPro Plus Pocket71084710842024-06-26
00610075094448VaPro Plus Pocket71104711042024-06-26
00610075094462VaPro Plus Pocket71124711242024-06-26
00610075099115CeraPlus89520895202026-05-29
00610075099122CeraPlus89530895302026-05-29
00610075099139CeraPlus89540895402026-05-29
00610075099146CeraPlus89601896012026-05-29
00610075099153CeraPlus89602896022026-05-29
00610075099160CeraPlus89603896032026-05-29
00610075093427Hollister934293422022-12-01
00610075093434Hollister934393432022-12-01
00610075097807Hollister978097802016-09-21
00610075097814Hollister978197812022-12-01
00610075097821Hollister978297822016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653599002476Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002452Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002483Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002254Men's LibertyARGENTUM MEDICAL, LLCNOA2024-06-07
10653599002251Men's LibertyARGENTUM MEDICAL, LLCNOA2024-06-07
00653599001943Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2024-02-07
00653599002162Men's LibertyARGENTUM MEDICAL, LLCNOA2024-02-07
10653599001940Men's Liberty AcuteBIODERM, INC.NOA2024-02-07
10653599002169Men's LibertyBIODERM, INC.NOA2024-02-07
00653599002186Men's LibertyARGENTUM MEDICAL, LLCNOA2024-02-07
00653599001950Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2023-10-05
10653599001957Men's Liberty AcuteBIODERM, INC.NOA2023-10-05
10687225793749PEDIATRIC URINE COLLECTORS, CLEANPRECISION DYNAMICS CORPORATIONNOA2023-06-20
00610075055975HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00610075098736HollisterHOLLISTER INCORPORATEDNOA2022-12-01
10610075055972HollisterHOLLISTER INCORPORATEDNOA2022-12-01
10610075055989HollisterHOLLISTER INCORPORATEDNOA2022-12-01
20610075098730HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00653599001837Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2022-06-23
10653599001834Men's Liberty AcuteBIODERM, INC.NOA2022-06-23
00653599001813Men's LibertyARGENTUM MEDICAL, LLCNOA2022-05-04
10653599001810Men's LibertyBIODERM, INC.NOA2022-05-04
00653599001790Men's LibertyARGENTUM MEDICAL, LLCNOA2021-12-20
00653599001806BioDerm (Men's Liberty Acute) 4-PackARGENTUM MEDICAL, LLCNOA2021-12-20
10653599001797Men's LibertyBIODERM, INC.NOA2021-12-20
10653599001803BioDerm (Men's Liberty Acute) 4-PackBIODERM, INC.NOA2021-12-20
00653599001639Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2021-09-20
10653599001636Men's Liberty AcuteBIODERM, INC.NOA2021-09-20
00653599001646Men's LibertyARGENTUM MEDICAL, LLCNOA2021-09-20
00653599001653Faceplate StripARGENTUM MEDICAL, LLCNOA2021-09-20