FDA.reportPublic FDA data

TSCD

Primary DI
34987350726972
Brand
TSCD
Company
TERUMO CORPORATION
Model
SC*W017
Device description
TSCD Wafers
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KSBSET, TRANSFER (BLOOD/PLASMA)

Product Code Classifications

CodeDeviceSpecialtyClass
KSBSet, Transfer (Blood/Plasma)Hematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34987350726972PackageGS12In Commercial Distribution
54987350726976PackageGS140In Commercial Distribution
04987350726971PrimaryGS10
84987350726977Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3498735072697234987350726972
5498735072697654987350726976
04987350726971049873507269714987350726971
8498735072697784987350726977

GMDN Terms

TermDefinition
Package sealing unitA mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00non-condensing, This way up, Fragile, handle with care, Stacking limit by 10, Keep away from sunlight, Keep dry
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(303)205-2510FDAUDIprogram@terumobct.com

Regulatory Flags

DUNS number
690543319
Device count
70
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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