FDA.reportPublic FDA data

Spectra Optia®

Primary DI
05020583102200
Brand
Spectra Optia®
Company
TERUMO BCT, INC.
Model
10220
Catalog number
10220
Device description
Exchange Set
Published
2021-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05020583102200PrimaryGS10
35020583102201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05020583102200050205831022005020583102200
3502058310220135020583102201

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight
Special Storage Condition, Specify00Protect from rain
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)339-4228FDAUDIprogram@terumobct.com

Regulatory Flags#

DUNS number
801679200
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05020583103108Spectra Optia®103102016-09-15
05020583610002Spectra Optia®610002016-09-15
05020583001145Reveos® Automated Whole Blood Processing System240002025-08-06
05020583826502Trima Accel826502023-06-19
05020583803664Trima Accel® 803662017-02-15
05020583804005Trima Accel®804002016-09-15
05020583824089Trima Accel® 824082016-09-15
05020583826601Trima Accel® 826602016-09-15
05020583826663Trima Accel® 826662017-02-15
05020583700512Blood Component Sampling Sets700512016-09-15
05020583803565Trima Accel® 803562017-02-15
05020583804401Trima Accel® 804402016-09-15
05020583824409Trima Accel® 824402016-09-15
05020583803503Trima Accel® 803502016-09-15
05020583803701Trima Accel® 803702016-09-15
05020583803404Trima Accel® 803402016-09-15
05020583803602Trima Accel® 803602016-09-15
05020583807006Trima Accel® 807002016-09-15
05020583804500Trima Accel® 804502016-09-15
05020583805002Trima Accel® 805002016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2024-03-27
00810020441192AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2023-05-24
00810020441208AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2023-05-23
05020583707009COBE® Spectra TERUMO BCT, INC.LKN2021-06-07
05020583909014COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583909045COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583909120COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583707000COBE® Spectra TERUMO BCT, INC.LKN2021-06-07
35020583909015COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583909046COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583909121COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
00810020440218AMICUS SeparatorFresenius Kabi AGLKN2021-02-09
00810020440249AMICUS SeparatorFresenius Kabi AGLKN2021-02-09
00810020440171AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2020-11-18
00810020440232AMICUS SeparatorFresenius Kabi AGLKN2020-10-20
04086000101912AMICUS Separator SoftwareFresenius Kabi AGLKN2020-01-21
04052682031717Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2019-02-20
04052682031724Waste Transfer SetFresenius Kabi AGLKN2019-02-20
04086000101950AMICUS Exchange Kit - TherapeuticsFresenius Kabi AGLKN2019-02-20
10812747012072HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATIONLKN2017-02-08
10812747012089HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATIONLKN2017-02-08
04086000901543TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
04052682003721P1R Plasma Treatment SetFresenius Kabi AGLKN2016-09-16
04086000860154COM.TECFresenius Kabi AGLKN2016-09-16
04086000901550TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
05020583103108Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
05020583610002Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
04086000100151AMICUS Exchange KitFresenius Kabi AGLKN2016-09-05
04086000100168Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2016-09-05