FDA.reportPublic FDA data

N/A

Primary DI
00817827025594
Brand
N/A
Company
CHARTER MEDICAL, LTD.
Model
T3000
Catalog number
T3000
Device description
150 mL Quad Aliquot Bag System
Published
2016-09-24
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9600430

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9600430

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817827025594PackageGS124In Commercial Distribution
00817827025099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817827025594008178270255948178270255940817827025594
00817827025099008178270250998178270250990817827025099

GMDN Terms#

Term, Definition table
TermDefinition
Paediatric blood donor setA sterile assembly consisting of multiple collection containers (typically five connected flexible bags) of smaller volume than those used in adult sets. It is used for the storage of adult donor blood which is decanted from a normal adult size pack into this device in order to create smaller paediatric volume packs for infusion. The individual paediatric packs are then separated and sealed for later infusion. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 458-3116CML_CustomerService@CharterMedical.com

Regulatory Flags#

DUNS number
029062325
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817827023019Cell FreezeCF-250CF-2502021-08-23
00817827023026Cell FreezeCF-250-3LCF-250-3L2021-08-23
00817827023033Cell FreezeCF-500CF-5002021-08-23
00817827023040Cell FreezeCF-500-3LCF-500-3L2021-08-23
00817827023057Cell FreezeCF-50CF-502021-08-23
00817827023064Cell FreezeCF-750CF-7502021-08-23
00817827023088Cell FreezeCML-75LNCML-75LN2021-08-23
00817827025044N/AC600C6002016-09-24
00817827025051N/AC605C6052016-09-24
00817827025129N/AT3006T30062016-09-24
00817827025136N/AT3101T31012016-09-24
00817827025143N/AT3104T31042016-09-24
00817827025150N/AT3106T31062016-09-24
00817827025167N/AT3106X2T3106X22016-09-24
00817827025174N/AT3107T31072016-09-24
00817827025181N/AT3108T31082016-09-24
00817827025198N/AT3109T31092016-09-24
00817827025204N/AT3110T31102016-09-24
00817827025211N/AT3194T31942016-09-24
00817827025228N/AT3400T34002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30812747019815Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
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