FDA.reportPublic FDA data

Hollister

Primary DI
00610075093458
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9345
Catalog number
9345
Device description
Extension Tubing with connector
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNZSYSTEM, URINE DRAINAGE, CLOSED, FOR NON-INDWELLING CATHETER, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075093452PackageGS14In Commercial Distribution
00610075093458PrimaryGS10
00610075151202Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007509345220610075093452
00610075093458006100750934586100750934580610075093458
00610075151202006100751512026100751512020610075151202

GMDN Terms#

Term, Definition table
TermDefinition
Urine drainage extension tubingA length of noninvasive flexible tubing intended to connect between a patient contact urinary drainage device (e.g., urethral catheter, urostomy pouch) and a receptacle; some types may in addition be intended for extra-urinary passive drainage applications (e.g., intestinal ostomy or wound drainage). It is typically self-applied; it does not include a valve or clamp (i.e., not a tubing set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length46Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
10
Premarket exempt
true
Kit
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
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
00610075097142Adapt780578052026-03-13
00610075097159Adapt780678062026-03-13
00610075097166Adapt781578152026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075093465HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
20610075093452HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
20610075093469HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
00840216101609ASP MEDICALAsp Global, LLCNNZ2022-04-15
10840216101606ASP MEDICALASP GLOBAL, LLCNNZ2022-04-15
05055788767640Leg Bag Holder Extra LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767671Leg Bag Holder LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767701Leg Bag Holder MediumFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767732Leg Bag Holder SmallFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
00815947020703CURE MEDICALCONVATEC, PURCHASING DEPARTMENTNNZ2016-09-24
20815947020707Cure Medical®CURE MEDICAL LLCNNZ2016-09-24