FDA.reportPublic FDA data

Apogee

Primary DI
00610075068487
Brand
Apogee
Company
HOLLISTER INCORPORATED
Model
10616Q
Device description
Urethral Intermittent Catheter, Straight Tip
Published
2022-07-15
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
K992137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992137000UROLOGICAL CATHETERApogee, Inc.1999-09-03GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610075068937PackageGS118In Commercial Distribution
00610075068487PrimaryGS10
00610075068777Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610075068937006100750689376100750689370610075068937
00610075068487006100750684876100750684870610075068487
00610075068777006100750687776100750687770610075068777

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 Gauge6French
Length16Inch

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
00610075096121VaPro73124731242026-08-13
00610075096138VaPro73144731442026-08-13
00610075096145VaPro73164731642026-08-13
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06
10610075029539CalciCare529937R529937R2022-12-01
10610075029546CalciCare529938R529938R2022-12-01
10610075029553CalciCare529939R529939R2022-12-01
10610075029560CalciCare529940R529940R2022-12-01
10610075029577CalciCare529967R529967R2022-11-01
10610075029584CalciCare529968R529968R2022-11-01
10610075029591CalciCare529969R529969R2022-11-01
10610075077158m9771577152022-12-01
10610075077172m9771777172022-12-01
10610075077325m9773277322022-12-01
10610075077332m9773377332022-12-01
10610075077349m9773477342022-12-01
10610075077356m9773577352022-12-01
10610075077363m9773677362022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704922649RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922656RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922663RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922670RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922687RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922694RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922700RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922717RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922724RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922731RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922748RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945433RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945440RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945457RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945464RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945471RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945488RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945495RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945501RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945518RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945815RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945822RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945839RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945853RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945860RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945877RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945884RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945891RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945907RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945914RUSCHTELEFLEX INCORPORATEDGBM2026-07-28