FDA.reportPublic FDA data

Magic3™ Intermittent Catheter

Primary DI
00801741068706
Brand
Magic3™ Intermittent Catheter
Company
C. R. Bard, Inc.
Model
53916
Catalog number
53916
Device description
Magic3™ Intermittent Catheter Antibacterial Coated Silicone, Male
Published
2016-07-23
Public version status
Update
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
MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJCCatheter, Urological (Antimicrobial) And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001143000RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERRochester Medical Corp.2000-07-07MJC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741068703PackageGS130In Commercial Distribution
20801741068700PackageGS1180In Commercial Distribution
00801741068706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174106870310801741068703
2080174106870020801741068700
00801741068706008017410687068017410687060801741068706

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 Gauge16French

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Combination product
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
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741017421Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741017438Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741017445Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741017452Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741039775Bardex® I.C. Temperature Sensing Foley CatheterC. R. Bard, Inc.MJC2016-08-06
00801741039782Bardex® I.C. Temperature Sensing Foley CatheterC. R. Bard, Inc.MJC2016-08-06
00801741039799Bardex® I.C. Temperature-Sensing Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039805Bardex® I.C. Temperature-Sensing Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039843Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039850Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039867Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039973Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741039980Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741039997Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040009Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040016Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040023Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040030Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040047Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040054Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040061Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040078Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040085Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040122Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040139Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040146Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741019364Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26
00801741019371Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26
00801741019388Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26
00801741019395Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26