FDA.reportPublic FDA data

PLEUR-EVAC

Primary DI
14026704631640
Brand
PLEUR-EVAC
Company
TELEFLEX INCORPORATED
Model
IPN028482
Catalog number
S-0500
Device description
PLEUR-EVAC MINI SAHARA LATEX FREE
Published
2019-07-09
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
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14026704631640Direct MarkingGS10
44026704631641PackageGS16In Commercial Distribution
34026704451716PreviousGS10
34026704631644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1402670463164014026704631640
4402670463164144026704631641
3402670445171634026704451716
3402670463164434026704631644

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
Depth2.25Inch
Length9Inch
Total Volume550Milliliter
Width7.5Inch

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704610904LMAIPN046748V1750152018-09-15
14026704610928LMAIPN046750V1750252018-09-15
14026704640277RUSCHIPN0499450044511002019-04-23
14026704641779RUSCHIPN0499380044311002019-04-24
14026704641793RUSCHIPN0499410044335002019-04-24
14026704641816RUSCHIPN0499430044490002019-04-24
14026704641823RUSCHIPN0499440044500502019-04-24
05060112311918LMAIPN046959V1250302018-09-15
10801902226119ARROWPR-45563-BASPR-45563-BAS2026-10-07
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
10801902225907ARROWPR-45541-BASPR-45541-BAS2026-10-06
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756402989DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756402996DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403009DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403016DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403023DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
14026704911773PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-08-01
04719874957476Create BiotechCREATE BIOTECH CO., LTD.KDQ2026-07-21
00850040296464AOJShenzhen AOJ Health Science & Technology Co., Ltd.KDQ2026-07-11
00850079671102NavägeRhinosystems, Inc.KDQ2026-06-10
14026704937247PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937254PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937261PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937278PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937285PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937292PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
40884389968100MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968124MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143020MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143518MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968070MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
14026704912190PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
14026704911780PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
14026704911902PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-07-02
14026704911872PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911889PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911896PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911919PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911926PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911933PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12