FDA.report

ARROW

Primary DI
20801902161271
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN915822
Catalog number
AH-05000
Device description
THERMODILUTION CATH KIT: 7 FR 4-L
Published
2020-01-21
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

Related Records

Contact Domains

Product Codes

CodeName
DYGCATHETER, FLOW DIRECTED

Product Code Classifications

CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20801902161271PackageGS15In Commercial Distribution
10801902161274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190216127120801902161271
1080190216127410801902161274

GMDN Terms

TermDefinition
Pulmonary artery catheter, thermal dilutionA flexible tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein and advanced to the pulmonary artery, to measure/monitor haematological parameters (e.g., pulmonary arterial pressures, intermittent cardiac output, cardiac index) using thermal dilution techniques; it may also be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included], and includes an exit port for the solution and an electrical component (e.g., thermistor) for temperature measurements. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge7French
Length110Centimeter

Storage And Handling

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
Ethylene Oxide

Contacts

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

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