FDA.reportPublic FDA data

Hollister

Primary DI
00610075093465
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9346
Catalog number
9346
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
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075093469PackageGS14In Commercial Distribution
00610075093465PrimaryGS10
00610075151219Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007509346920610075093469
00610075093465006100750934656100750934650610075093465
00610075151219006100751512196100751512190610075151219

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
Length0

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
10
DM exempt
false
Premarket exempt
true
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
10610075180292Advance Plus Pocket93104IC93104IC2016-09-21
10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
10610075180315Advance Plus Pocket93144IC93144IC2016-09-21
10610075180322Advance Plus Pocket93164IC93164IC2016-09-21
00610075077243Hollister772477242022-12-01
00610075077281Hollister772877282022-12-01
00610075095667VaPro Plus Pocket Kit79089K79089K2024-07-15
00610075095674VaPro Plus Pocket Kit79109K79109K2024-07-15
00610075095681VaPro Plus Pocket Kit79129K79129K2024-07-15
00610075095698VaPro Plus Pocket Kit79149K79149K2024-07-15
00610075095704VaPro Plus Pocket Kit79169K79169K2024-07-15
00610075096541VaPro Plus Pocket Kit79089K79089K2025-01-24
00610075096602VaPro Plus Pocket Kit79109K79109K2025-01-24
00610075096619VaPro Plus Pocket Kit79129K79129K2025-01-24
00610075096626VaPro Plus Pocket Kit79149K79149K2025-01-24
00610075096633VaPro Plus Pocket Kit79169K79169K2025-01-24
00610075102082Advance Plus96064IC96064IC2016-09-21
00610075102099Advance Plus96084IC96084IC2016-09-21
00610075102105Advance Plus96104IC96104IC2016-09-21
00610075102112Advance Plus96124IC96124IC2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941298160523RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161292RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161308RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161315RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161322RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
04046961018612ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
04046961018650ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
00850063139496Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139502Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139519Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139526Neil Medical Group Neil Medical GroupFAQ2025-12-08
06975424198265Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198289Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198302Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198326Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198340Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198364Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198388Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198269Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198283Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198306Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198320Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198344Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198368Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198382Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06974500612558Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
06974500612565Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
06974500612572Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612555Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612562Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07