FDA.report

TERUFLEX TRANSFER BAG

Primary DI
34987350704536
Brand
TERUFLEX TRANSFER BAG
Company
TERUMO CORPORATION
Model
BB*T100BB71
Device description
TERUFLEX TRANSFER BAG
Published
2016-09-15
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
KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Product Code Classifications

CodeDeviceSpecialtyClass
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34987350704536PackageGS125In Commercial Distribution
54987350704530PackageGS14In Commercial Distribution
04987350704535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3498735070453634987350704536
5498735070453054987350704530
04987350704535049873507045354987350704535

GMDN Terms

TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume1000Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep away from rain
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
3032052510FDAUDIprogram@terumobct.com

Regulatory Flags

DUNS number
690543319
Device count
1
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04987350740601GLIDEWIRE GT-RGT*GW1618AGT*GW1618A2026-02-06
04987350740625GLIDEWIRE GT-RGT*GA1818AGT*GA1818A2026-02-06
04987350740649GLIDEWIRE GT-RGT*GA1822AGT*GA1822A2026-02-06
54987350740668GLIDEWIRE GT-RGT*GE1818AGT*GE1818A2026-02-06
04987350740687GLIDEWIRE GT-RGT*GE1822AGT*GE1822A2026-02-06
54987350740699GLIDEWIRE GT-RGT*GW1818AGT*GW1818A2026-02-06
04987350740700GLIDEWIRE GT-RGT*GW1822AGT*GW1822A2026-02-06
04987350745422GLIDEWIRE GT-RGT*GW1622AGT*GW1622A2026-02-06
04987350744487DUALVIEWTU-DSS01CTU*DV01U2026-01-21
54953170465050VISIGLIDEG-240-2527AN36222312025-07-14
54953170465067VISIGLIDEG-240-2545AN36224312025-07-14
54953170465074VISIGLIDEG-240-3527AN36226312025-07-14
54953170465081VISIGLIDEG-240-3545AN36228312025-07-14
54953170465098VISIGLIDEG-240-2527SN36221312025-07-14
54953170465104VISIGLIDEG-240-2545SN36223312025-07-14
54953170465111VISIGLIDEG-240-3527SN36225312025-07-14
54953170465128VISIGLIDEG-240-3545SN36227312025-07-14
54953170465135VISIGLIDE2G-260-2527AN53677312025-07-14
54953170465142VISIGLIDE2G-260-2545AN53681312025-07-14
54953170465159VISIGLIDE2G-260-3527AN53679312025-07-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00812747019814Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
20816203023906CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024057CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024064CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024200CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024217CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024224CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024231CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024248CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024255CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024286CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024309CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024316CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10810020441748Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
10810020441380Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15
10810020440512Adaptive Nomogram Transfer PackFresenius Kabi AGKSR2024-12-12
20816203021100CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2024-12-06
20816203023753CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2024-12-06
00812747019807Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2024-10-10
14719878520468PuribloodPURIBLOOD MEDICAL CO., LTD.KSR2024-02-16
14719878520475PuribloodPURIBLOOD MEDICAL CO., LTD.KSR2024-02-16
14719878520482PuribloodPURIBLOOD MEDICAL CO., LTD.KSR2024-02-16
14719878520499PuribloodPURIBLOOD MEDICAL CO., LTD.KSR2024-02-16
14719878520505PuribloodPURIBLOOD MEDICAL CO., LTD.KSR2024-02-16
14719878520512PuribloodPURIBLOOD MEDICAL CO., LTD.KSR2024-02-16
20816203023722CryoStoreORIGEN BIOMEDICAL, INC.KSR2023-03-15
20816203023739CryoStoreORIGEN BIOMEDICAL, INC.KSR2023-03-15
20816203023746CryoStoreORIGEN BIOMEDICAL, INC.KSR2023-03-15
05020583419506IMUGARDTERUMO BCT, INC.KSR2022-11-23
04052682039164Transfer Pack Container with Coupler - 2000 mLFresenius Kabi AGKSR2022-06-24