FDA.reportPublic FDA data

Spectra Optia®

Primary DI
05020583103108
Brand
Spectra Optia®
Company
TERUMO BCT, INC.
Model
10310
Device description
IDL Set
Published
2016-09-15
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
GKTSeparator, automated, blood cell, diagnostic
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKTSeparator, Automated, Blood Cell, DiagnosticHematology2
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1502510

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1502510

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35020583103109PackageGS16In Commercial Distribution
05020583103108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3502058310310935020583103109
05020583103108050205831031085020583103108

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
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
05020583805507Trima Accel® 805502016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10812747019859Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
30812747019853Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
00811137013104Amicus SeparatorFresenius Kabi AGGKT2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGGKT2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGGKT2026-02-03
04086000100090AMICUS Apheresis Kit – Single NeedleFresenius Kabi AGGKT2025-11-03
00810020440560Aurora XiFresenius Kabi AGGKT2025-02-26
00810020442199Aurora XiFresenius Kabi AGGKT2025-02-26
04086000100052AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGGKT2024-10-30
14086000100059AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGGKT2024-10-30
10812747019279Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
10812747019347Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
30812747019273Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
30812747019341Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
10812747019736Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2024-07-17
30812747019730Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2024-07-17
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2024-03-27
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGGKT2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGGKT2024-03-27
00810020441635Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
00810020441642Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
10810020441632Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
10810020441649Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
04086000101035ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AGGKT2023-12-13
14086000101032ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AGGKT2023-12-13
10812747019330Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2023-06-29
30812747019334Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2023-06-29
05020583826502Trima AccelTERUMO BCT, INC.GKT2023-06-19
35020583826503Trima AccelTERUMO BCT, INC.GKT2023-06-19