FDA.report

PLEUR-EVAC

Primary DI
34026704631675
Brand
PLEUR-EVAC
Company
TELEFLEX INCORPORATED
Model
IPN028485
Catalog number
S-1102-08LF
Device description
PLEUR-EVAC SAHARA DRY SUCTION/DRY SEAL DUAL LATEX FREE
Published
2019-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CACAPPARATUS, AUTOTRANSFUSION

Product Code Classifications

CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704631675Direct MarkingGS10
44026704631672PackageGS16In Commercial Distribution
04026704417469PreviousGS10
14026704631671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670463167534026704631675
4402670463167244026704631672
04026704417469040267044174694026704417469
1402670463167114026704631671

GMDN Terms

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

TypeValueUnit
Depth3.5Inch
Device Size Text, specify0
Height10.5Inch
Width11.25Inch

Sterilization Methods

Method

Contacts

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

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