FDA.reportPublic FDA data

Onli

Primary DI
20610075056334
Brand
Onli
Company
HOLLISTER INCORPORATED
Model
82141-30
Device description
Ready to Use Hydrophilic Intermittent Catheter, 14 Fr 6.7 in/17cm, Straight
Published
2017-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K163179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163179000Onli Intermittent CatheterHollister Incorporated2017-01-26GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075056334PackageGS110In Commercial Distribution
00610075056330PrimaryGS10
00610075061921Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007505633420610075056334
00610075056330006100750563306100750563300610075056330
00610075061921006100750619216100750619210610075061921

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
Length6.7Inch

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
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

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Primary DI, Brand, Company table
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14026704943194TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943255TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
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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