FDA.reportPublic FDA data

Transfer Pack

Primary DI
20811137010541
Brand
Transfer Pack
Company
FENWAL, INC.
Model
4R2014
Catalog number
4R2014
Device description
Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811137010541PackageGS18Not in Commercial Distribution
10811137010544PrimaryGS10
0FE04R2014SecondaryICCBBA0
00811137010547Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081113701054120811137010541
1081113701054410811137010544
00811137010547008111370105478111370105470811137010547

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-933-6925xx@xx.xx

Regulatory Flags#

DUNS number
794519020
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137010462NA4C23004C23002016-09-12
00811137010769NA4R24224R24222016-09-12
10811137010490Transfer Pack4R20324R20322016-09-12
10811137010612Transfer Pack4R20014R20012016-09-12
10811137010629Transfer Pack4R20044R20042016-09-12
00811137010486Leukoconnect4C43004C43002016-09-12
20811137010626Transfer Pack4R20044R20042016-09-12
10811137010544Transfer Pack4R20144R20142016-09-12
10811137010551Transfer Pack4R20244R20242016-09-12
10811137010636Transfer Pack4R20234R20232016-09-12
00811137010738Transfer Pack4R20274R20272016-09-12
20811137010497Transfer Pack4R20324R20322016-09-12
20811137010619Transfer Pack4R20014R20012016-09-12
00811137012916ALYX Plasma Kit4R57304R57302016-09-08
00811137010400NA4C21614C21612016-09-12
00811137010431NA4C45024C45022016-09-12
00811137010455NA4C21604C21602016-09-12
00811137010691NA4C22234C22232016-09-12
00811137010714NA4C24684C24682016-09-12
00811137012411Apheresis Needle with MASTERGUARD Protector4R24414R24412016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812747019814Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
10816203023909CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024050CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024067CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024203CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024210CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024227CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024234CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024241CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024258CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024289CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024302CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024319CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
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
00810020441741Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
10810020441748Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
00810020441383Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15
10810020441380Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15