FDA.reportPublic FDA data

Apogee

Primary DI
00610075068500
Brand
Apogee
Company
HOLLISTER INCORPORATED
Model
11016Q
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
00610075068951PackageGS118In Commercial Distribution
00610075068500PrimaryGS10
00610075068890Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610075068951006100750689516100750689510610075068951
00610075068500006100750685006100750685000610075068500
00610075068890006100750688906100750688900610075068890

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 Gauge10French
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
00610075040070InstaFlo330162016-09-21
00610075052332Apogee HC908102016-09-21
00610075052349Apogee HC910062016-09-21
00610075052356Apogee HC910102016-09-21
00610075052363Apogee HC912062016-09-21
00610075052370Apogee HC912162016-09-21
00610075052387Apogee HC914062016-09-21
00610075052394Apogee HC914162016-09-21
00610075052400Apogee HC916162016-09-21
00610075052417Apogee HC918162016-09-21
00610075052424Apogee HC912262016-09-21
00610075052431Apogee HC914262016-09-21
00610075052448Apogee HC916262016-09-21
10610075117250Premier89005890052022-12-01
10610075198631New Image19503195032022-12-01
00610075198443Adapt7730US2018-01-01
00610075198450Adapt7731US2018-01-01
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704945624RUSCHTELEFLEX INCORPORATEDGBM2026-07-23
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14026704943019TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943026TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943033TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943040TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
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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
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10192253058505DoverCardinal Health 200, LLCGBM2025-01-23
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10192253058529DoverCardinal Health 200, LLCGBM2025-01-23
10192253058536DoverCardinal Health 200, LLCGBM2025-01-23
10192253058543DoverCardinal Health 200, LLCGBM2025-01-23