FDA.report

ARROW

Primary DI
20801902143741
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN029628
Catalog number
ASK-00622-AU
Device description
EXT DWELL CATH DEVICE 22GAX6CM
Published
2018-10-31
Public version status
Update
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
FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20801902143741PackageGS15In Commercial Distribution
10801902143744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190214374120801902143741
1080190214374410801902143744

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid freezing and excessive heat above 40C (104F).
Special Storage Condition, Specify00Store between 15 - 30°C (59 - 86°F). Avoid freezing and excessive heat above 40°C (104°F).
Special Storage Condition, Specify00 Avoid freezing and excessive heat above 40°C (104°F).
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

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