FDA.report

PILLING

Primary DI
34026704734253
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN916133
Catalog number
351470
Device description
JEHLE Catheter 9/32" STERILE 5 per Box
Published
2020-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KRACatheter, continuous flush

Product Code Classifications

CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704734256PackageGS15In Commercial Distribution
34026704734253PackageGS112In Commercial Distribution
14026704734259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2402670473425624026704734256
3402670473425334026704734253
1402670473425914026704734259

GMDN Terms

TermDefinition
Coronary sinus cannulaA sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into the ostium of the coronary sinus to provide retrograde coronary perfusion/cardioplegia during cardiopulmonary bypass or minimally invasive surgery. It may be equipped with a self-inflating low pressure balloon that is typically used for back flushing the coronary vessel in the event of inadvertent coronary air embolization. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.

Sterilization Methods

Method

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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