FDA.reportPublic FDA data

ARROW

Primary DI
20801902160588
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN915246
Catalog number
AI-07167
Device description
CATH PKGD: THERMISTOR 7 110CM
Published
2019-12-11
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#

Product Codes#

Code, Name table
CodeName
DYGCATHETER, FLOW DIRECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902160588PackageGS15In Commercial Distribution
10801902160581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190216058820801902160588
1080190216058110801902160581

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing balloon catheterA sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Length110Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
50690103218287SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
50690103218638SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103217094Swan-GanzEdwards Lifesciences LLCDYG2025-07-11
20801902206330ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206439ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902206453ARROWTELEFLEX INCORPORATEDDYG2022-10-20
20801902209379ARROWTELEFLEX INCORPORATEDDYG2022-05-20
20801902208976ARROWTELEFLEX INCORPORATEDDYG2022-03-18
20801902206644ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206651ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206668ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206675ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206712ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206729ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206736ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902206743ARROWTELEFLEX INCORPORATEDDYG2022-03-14
20801902180319ARROWTELEFLEX INCORPORATEDDYG2021-08-27
20801902180326ARROWTELEFLEX INCORPORATEDDYG2021-08-27
20801902180333ARROWTELEFLEX INCORPORATEDDYG2021-08-27
20801902180357ARROWTELEFLEX INCORPORATEDDYG2021-08-27
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20801902180371ARROWTELEFLEX INCORPORATEDDYG2021-08-27
20801902180302ARROWTELEFLEX INCORPORATEDDYG2021-08-26
20801902180265ARROWTELEFLEX INCORPORATEDDYG2021-08-19
20801902180296ARROWTELEFLEX INCORPORATEDDYG2021-08-19
20801902180814ARROWTELEFLEX INCORPORATEDDYG2021-08-19
04046955651702CORODYNB. BRAUN MEDICAL INC.DYG2021-08-18
04046955651542CORODYNB. BRAUN MEDICAL INC.DYG2021-08-17
04046955651580CORODYNB. BRAUN MEDICAL INC.DYG2021-08-17