FDA.reportPublic FDA data

PLEUR-EVAC

Primary DI
14026704911919
Brand
PLEUR-EVAC
Company
TELEFLEX INCORPORATED
Model
IPN927563
Catalog number
A-7002-08LF
Device description
PLEUR-EVAC ADULT-PEDIATRIC WET DUAL COLLECTION LATEX FREE
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924337000PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYSDeknatel, Inc.1993-07-28GCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704911916Direct MarkingGS10
34026704911913PackageGS16In Commercial Distribution
14026704921864PreviousGS10
14026704911919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670491191624026704911916
3402670491191334026704911913
1402670492186414026704921864
1402670491191914026704911919

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic suction collection containerA device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth2.5Inch
Length16.5Inch
Total Volume2850Milliliter
Width12.75Inch

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29
10841156108502ONCONTROLIPN9190199458-VC-0062021-10-29
10841156108564ONCONTROLIPN9190259463-VC-0062021-10-29
10841156108601ONCONTROLIPN9190299465-VC-0062021-10-29
10841156108632ONCONTROLIPN9190329468-VC-0062022-01-20
10841156108649ONCONTROLIPN9190339471-VC-0062022-01-21
10841156108656ONCONTROLIPN9190349472-VC-0062021-10-29
10841156108663ONCONTROLIPN9190359490-VC-0062022-01-20
10841156108670ONCONTROLIPN9190159408-VC-0062021-10-29
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344219254MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-10-16
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
06936603230008SafeSnapYangzhou Fartley Medical Instrument Technology Co., LtdKDQ2025-06-13
06936603230022SafeSnapYangzhou Fartley Medical Instrument Technology Co., LtdKDQ2025-06-13
14026704911872PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911889PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911896PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12