FDA.report

SureTrans Autotransfusion System for Orthopaedics

Primary DI
10801741065429
Brand
SureTrans Autotransfusion System for Orthopaedics
Company
Davol Inc.
Model
8594000
Catalog number
8594000
Device description
SureTrans Autotransfusion System for Orthopaedics with PVC Drain and 2 Trocars
Published
2015-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10801741065429PackageGS16In Commercial Distribution
20801741065426PackageGS13In Commercial Distribution
00801741065422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174106542910801741065429
2080174106542620801741065426
00801741065422008017410654228017410654220801741065422

GMDN Terms

TermDefinition
Blood-processing autotransfusion systemAn assembly of devices designed to collect and process blood lost by a patient to obtain red blood cells for subsequent reinfusion into the same patient (i.e., autotransfusion). It typically includes a disposable suction system to collect blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., a centrifuge) to separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate microfilters, and a reinfusion bag that stores the red blood cells in saline. The system is used mainly during surgical procedures to minimize allogeneic blood use, but may be used postoperatively and in emergency or intensive care units.

Device Sizes

TypeValueUnit
Outer Diameter1Inch
Outer Diameter6.3Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags

DUNS number
001191048
Device count
1
DM exempt
false
Premarket exempt
false
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

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