FDA.reportPublic FDA data

Marketlab Inc

Primary DI
00817517020762
Brand
Marketlab Inc
Company
MARKETLAB INC.
Model
42468
Catalog number
42468
Device description
30cc/24Fr 100% Silicone Foley Catheter PK12
Published
2018-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160235000ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc.2016-06-30FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817517020762PrimaryGS10
00817517021455Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517020762008175170207628175170207620817517020762
00817517021455008175170214558175170214550817517021455

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866) 237-3722service@marketlabinc.com

Regulatory Flags#

DUNS number
848917027
Device count
12
Kit
true
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
00817518026107MarketLab, Inc.108165-FSC-AEL2026-07-16
00817518026268MarketLab, Inc.1000442-FSC2026-07-16
00817518026275MarketLab, Inc.1000443-FSC2026-07-16
00817518024523MarketLab, Inc.1087812025-12-18
00817643023972Hopkins1380422024-02-02
00817517027938Marketlab-Clinton1387632024-02-02
00817517027945Marketlab-Clinton1387642024-02-02
00817517027952Marketlab-Clinton1387652024-02-02
00817517027969Marketlab-Clinton1387662024-02-02
00817517027976Marketlab-Clinton1387672024-02-02
00817517027983Marketlab-Clinton1387682024-02-02
00817517027990Marketlab-Clinton1387692024-02-02
00817517028003Marketlab-Clinton1387702024-02-02
00817517028072Marketlab-Clinton1387712024-02-02
00817517028089Marketlab-Clinton1387722024-02-02
00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
00817517028126Marketlab-Clinton1387762024-02-02
00817517028133Marketlab-Clinton1387772024-02-02

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