FDA.reportPublic FDA data

Onli

Primary DI
00610075097449
Brand
Onli
Company
HOLLISTER INCORPORATED
Model
85144
Catalog number
85144
Device description
Urethral Intermittent Catheter, Coudé Tip
Published
2026-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K211436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211436000Intermittent Catheter (Not Finalized)Hollister Incorporated2022-01-27GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075097446PackageGS110In Commercial Distribution
00610075097449PrimaryGS10
20610075097443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007509744610610075097446
00610075097449006100750974496100750974490610075097449
2061007509744320610075097443

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 Gauge14French
Catheter Length40Centimeter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
30
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
14026704943019TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943026TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943033TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943040TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943057TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943125TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943132TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943149TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943170TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943194TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943255TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
10192253058437DoverCardinal Health 200, LLCGBM2025-01-23
10192253058444DoverCardinal Health 200, LLCGBM2025-01-23
10192253058451DoverCardinal Health 200, LLCGBM2025-01-23
10192253058468DoverCardinal Health 200, LLCGBM2025-01-23
10192253058475DoverCardinal Health 200, LLCGBM2025-01-23
10192253058482DoverCardinal Health 200, LLCGBM2025-01-23
10192253058499DoverCardinal Health 200, LLCGBM2025-01-23
10192253058505DoverCardinal Health 200, LLCGBM2025-01-23
10192253058512DoverCardinal Health 200, LLCGBM2025-01-23
10192253058529DoverCardinal Health 200, LLCGBM2025-01-23
10192253058536DoverCardinal Health 200, LLCGBM2025-01-23
10192253058543DoverCardinal Health 200, LLCGBM2025-01-23
00610075094394VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094400VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094424VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094431VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094448VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094462VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
10192253027761DoverCardinal Health 200, LLCGBM2022-11-08