FDA.reportPublic FDA data

N/A

Primary DI
00817827021121
Brand
N/A
Company
CHARTER MEDICAL, LTD.
Model
03-220-BD
Catalog number
03-220-BD
Device description
Plasma/Fluid Transfer Set with Tube Adapter
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
KSBSet, Transfer (Blood/Plasma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSBSet, Transfer (Blood/Plasma)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0500210

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0500210

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817827021626PackageGS148Not in Commercial Distribution
00817827021121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817827021626008178270216268178270216260817827021626
00817827021121008178270211218178270211210817827021121

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.

Contacts#

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

Regulatory Flags#

DUNS number
029062325
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
35020583260314SCD Welding WaferTERUMO BCT, INC.KSB2025-05-14
55020583260318SCD Welding WaferTERUMO BCT, INC.KSB2025-05-14
04987488104139K-Shield Advantage Blood Drawing KitSB-KAWASUMI LABORATORIES, INC.KSB2024-12-24
06976052440061BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
16976052440068BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
06976052440092BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
00866305000264Genesis RapidWeld II STW Sterile Tube WelderGENESIS BPS LLCKSB2022-07-26
10866305000278TCD B40 WafersGENESIS BPS LLCKSB2022-07-19
10866305000230RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000247RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000254RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000223TCD B40 WafersGENESIS BPS LLCKSB2019-10-29
00646311630033BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTOSB-KAWASUMI LABORATORIES, INC.KSB2019-02-26
00646311630040K-Shield Advantage Blood Drawing KitSB-KAWASUMI LABORATORIES, INC.KSB2019-02-13
00817827026171AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026188AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026195AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026201AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026218AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026676AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026683AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026690AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026706AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026713AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00887868260285Rejuvesol™Citra Labs, LLCKSB2018-07-13
14052682004169Fenwal Plasma Transfer Sets with Two SpikesFresenius Kabi AGKSB2018-05-29
24052682004166Fenwal Plasma Transfer Sets with Two SpikesFresenius Kabi AGKSB2018-05-29
00817827026010Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026027Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026034Advect™CHARTER MEDICAL, LTD.KSB2018-04-10