MTG Jiffy Cath™ Coude

Primary DI
10851593006880
Brand
MTG Jiffy Cath™ Coude
Company
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
Model
22612
Device description
Pre-Lubricated Closed System Intermittent Catheter - Kit
Published
2019-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10851593006880PackageGS1100In Commercial Distribution
00851593006883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085159300688010851593006880
00851593006883008515930068838515930068830851593006883

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
011005491
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00851593006432MTG Eagle Board1002018-01-23
00851593006944MTG Jiffy Cath™ Coude - PVP kit216142019-10-30
00851593006951MTG Jiffy Cath™ Coude - PVP kit216142019-10-30
00851593006753MTG Jiffy Cath™ Mini-Pak121122019-09-10
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