FDA.reportPublic FDA data

Mongoose

Primary DI
74543527226409
Brand
Mongoose
Company
TOGO MEDIKIT CO.,LTD.
Model
A-5MP-80/0037
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113819000MONGOOSE ANGIOGRAPHIC CATHETERPediacath, Inc.2012-07-11DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14543527226407PackageGS13In Commercial Distribution
74543527226409PackageGS110In Commercial Distribution
04543527226400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454352722640714543527226407
7454352722640974543527226409
04543527226400045435272264004543527226400

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store this product in a cool, dark, dry place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690724240
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04543527266895Super Sheath XLCI10L11TG00352025-03-13
04543527266901Super Sheath XLCI10L11TP00382025-03-13
04543527266918Super Sheath XLCI11L11TG00352025-03-13
04543527266925Super Sheath XLCI11L11TP00382025-03-13
04543527266932Super Sheath XLCI12L11TG00352025-03-13
04543527266949Super Sheath XLCI12L11TP00382025-03-13
04543527266956Super Sheath XLCI14L11TG00352025-03-13
04543527266963Super Sheath XLCI14L11TP00382025-03-13
04543527266970Super Sheath XLCI10L25TP00382025-03-13
04543527266987Super Sheath XLCI11L25TP00382025-03-13
04543527266994Super Sheath XLCI12L25TP00382025-03-13
04543527267007Super Sheath XLCI14L25TP00382025-03-13
04543527267014Super SheathBT40Z07PGW0352025-03-13
04543527267021Super SheathBT50Z07PGW0352025-03-13
04543527267038Super SheathBT60Z07PGW0352025-03-13
04543527267045Super SheathBT60Z07PGW0382025-03-13
04543527267052Super SheathBT70Z07PGW0352025-03-13
04543527267076Super SheathBT40Z11PPW0352025-03-13
04543527267083Super SheathBT50Z11PGW0352025-03-13
04543527267090Super SheathBT50Z11PGW0382025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24