FDA.reportPublic FDA data

PLEUR-EVAC

Primary DI
34026704631590
Brand
PLEUR-EVAC
Company
TELEFLEX INCORPORATED
Model
IPN028478
Catalog number
PE101
Device description
PLEUR EVAC CONNECTOR 3/8 Y
Published
2019-05-08
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
GCDCONNECTOR, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704631590PackageGS120In Commercial Distribution
04026704558650PreviousGS10
14026704631596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3402670463159034026704631590
04026704558650040267045586504026704558650
1402670463159614026704631596

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Inch

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
true
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937223PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937377PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937384PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937391PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937407PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937339PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-07
14026704911858PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-04-29
10192253042900ArgyleCardinal Health 200, LLCGCD2025-03-07
10192253042832ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042856ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042863ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042870ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042887ArgyleCardinal Health 200, LLCGCD2025-02-27
14026704933126PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933133PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933140PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933157PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
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14710961934971Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961934988Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961934995Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935008Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935015Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935022Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935039Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935046Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935053Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935060Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935077Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935084Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31