FDA.reportPublic FDA data

PILLING

Primary DI
24026704734263
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN916134
Catalog number
351472
Device description
JEHLE Catheter 11/32" 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704734263PackageGS15In Commercial Distribution
34026704734260PackageGS112In Commercial Distribution
14026704734266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670473426324026704734263
3402670473426034026704734260
1402670473426614026704734266

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length52Centimeter
Width0.34375Inch

Sterilization Methods#

Method table
Method

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

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
10884450826178Fountain®Merit Medical Systems, Inc.KRA2026-03-21
10884450470418Fountain®Merit Medical Systems, Inc.KRA2026-03-19
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-03-13
00860008103819Recana Debulking CatheterIntervene, Inc.KRA2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.KRA2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.KRA2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.KRA2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.KRA2026-03-02
10884450826352Fountain®Merit Medical Systems, Inc.KRA2026-02-21
10884450826222Fountain®Merit Medical Systems, Inc.KRA2026-02-18
10884450826543Fountain®Merit Medical Systems, Inc.KRA2026-02-14
10884450826635Fountain®Merit Medical Systems, Inc.KRA2026-02-14
G544ADM18130Agile AnglerAgile Devices, Inc.KRA2026-01-30
G544ADM18147Agile AnglerAgile Devices, Inc.KRA2026-01-30
10884450826185Fountain®Merit Medical Systems, Inc.KRA2026-01-29
10884450826208Fountain®Merit Medical Systems, Inc.KRA2026-01-16
00884450742921Merit Maestro®Merit Medical Systems, Inc.KRA2026-01-03
10884450826512Fountain®Merit Medical Systems, Inc.KRA2025-11-12
00857136004316TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00857136004323TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00884450742914Merit Maestro®Merit Medical Systems, Inc.KRA2025-09-19
10884450826420Fountain®Merit Medical Systems, Inc.KRA2025-08-06
10884450826482Fountain®Merit Medical Systems, Inc.KRA2025-06-03
10884450825997Fountain®Merit Medical Systems, Inc.KRA2025-05-16
10884450825546Fountain®Merit Medical Systems, Inc.KRA2025-05-13
10884450826413Fountain®Merit Medical Systems, Inc.KRA2025-05-13
00842429106228PG PROMICROVENTION INC.KRA2025-04-30
00842429118733VIA MicrocatheterMICROVENTION INC.KRA2025-04-30