FDA.reportPublic FDA data

Spectra Optia®

Primary DI
05020583112209
Brand
Spectra Optia®
Company
TERUMO BCT, INC.
Model
11220
Catalog number
11220
Device description
Single-Needle Connector
Published
2021-06-03
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35020583112200PackageGS112In Commercial Distribution
05020583112209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3502058311220035020583112200
05020583112209050205831122095020583112209

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
Kit
true
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