FDA.report

THORATEC® VAD, SEALED ARTERIAL CANNULA, LONG, STRAIGHT, 14MM

Primary DI
00813024012467
Brand
THORATEC® VAD, SEALED ARTERIAL CANNULA, LONG, STRAIGHT, 14MM
Company
Thoratec Corporation
Model
100121
Catalog number
100121
Published
2014-09-20
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
DSQVentricular (Assisst) Bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DSQVentricular (Assist) BypassUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813024012467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813024012467008130240124678130240124670813024012467

GMDN Terms

TermDefinition
Implantable ventricular circulatory assist system outflow cannula, animal-derivedA sterile, implantable tube which includes animal-derived materials (e.g., synthetic polymer sealed with mammalian gelatin), intended to function as an outflow for an implantable ventricular circulatory assist system, to channel blood pumped from the left ventricle into the aorta via a surgically-created anastomosis.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
070156955
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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