FDA.reportPublic FDA data

MTG Jiffy Cath™ Mini-Pak

Primary DI
00851593006753
Brand
MTG Jiffy Cath™ Mini-Pak
Company
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
Model
12112
Device description
Pre-Lubricated Closed System Intermittent Catheter
Published
2019-09-10
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
KODCatheter, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080878000MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)Medical Technologies of Georgia, Inc.2008-07-17KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851593006750PackageGS1100In Commercial Distribution
00851593006753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085159300675010851593006750
00851593006753008515930067538515930067530851593006753

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry , Keep away from direct sunlight

Contacts#

Phone, Email table
PhoneEmail
770-788-0763MTGcustomerservice@medtechga.com

Regulatory Flags#

DUNS number
011005491
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851593006432MTG Eagle Board1002018-01-23
00851593006944MTG Jiffy Cath™ Coude - PVP kit216142019-10-30
00851593006951MTG Jiffy Cath™ Coude - PVP kit216142019-10-30
00851593006760MTG Jiffy Cath™ Mini-Pak121142019-09-10
00851593006777MTG Jiffy Cath™ Mini-Pak121162019-09-10
00851593006784MTG Jiffy Cath™201122019-09-10
00851593006791MTG Jiffy Cath™201142019-09-10
00851593006807MTG Jiffy Cath™201162019-09-10
00851593006814MTG Jiffy Cath™ Coude206122019-09-10
00851593006821MTG Jiffy Cath™ Coude206142019-09-10
00851593006838MTG Jiffy Cath™ Coude206162019-09-10
00851593006845MTG Jiffy Cath™211142019-09-10
00851593006852MTG Jiffy Cath™221122019-09-10
00851593006869MTG Jiffy Cath™221142019-09-10
00851593006876MTG Jiffy Cath™221162019-09-10
00851593006883MTG Jiffy Cath™ Coude226122019-09-10
00851593006890MTG Jiffy Cath™ Coude226142019-09-10
00851593006906MTG Jiffy Cath™ Coude226162019-09-10
00851593006913MTG Jiffy Cath™ Soft / Coude227122019-09-10
00851593006920MTG Jiffy Cath™ Soft / Coude227142019-09-10

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Primary DI, Brand, Company table
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