FDA.reportPublic FDA data

PLEUR-EVAC

Primary DI
34026704631651
Brand
PLEUR-EVAC
Company
TELEFLEX INCORPORATED
Model
IPN028483
Catalog number
S-100-08LF
Device description
PLEUR-EVAC SAHARA AUTOTRANSFUSION BAG LATEX FREE
Published
2019-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CACAPPARATUS, AUTOTRANSFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704631651Direct MarkingGS10
44026704631658PackageGS16In Commercial Distribution
04026704410842PreviousGS10
14026704631657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3402670463165134026704631651
4402670463165844026704631658
04026704410842040267044108424026704410842
1402670463165714026704631657

GMDN Terms#

Term, Definition table
TermDefinition
Whole-blood-recovery autotransfusion system, poweredAn assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth2.5Inch
Device Size Text, specify0
Height11Inch
Width5.5Inch

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
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
14026704937230PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937308PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937315PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704912206PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704912213PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704911797PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911803PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911865PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
08033178113700XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113717XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113724XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113939XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113946XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113953XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113984XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLCAC2024-12-20