FDA.reportPublic FDA data

Typesafe 2.0

Primary DI
10812269031230
Brand
Typesafe 2.0
Company
TYPENEX MEDICAL LLC
Model
SP0201QD
Device description
Typesafe 2.0 - Quantity 500
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1503510

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1503510

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812269031240PackageGS11In Commercial Distribution
10812269031230PrimaryGS10
00812269031233Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812269031240008122690312408122690312400812269031240
1081226903123010812269031230
00812269031233008122690312338122690312330812269031233

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor bag segment sampling IVDA sampling device intended to be used for extracting a blood specimen from a blood donor bag tubing segment for analysis and/or other investigation (e.g., blood grouping, cross matching). It typically consists of a needle surrounded by plastic housing designed so that the blood-filled tubing segment may be inserted into the housing, pierced by the needle, and a sample manually extracted without exposing the user to either the blood or the needle. This is a single-use device.

Regulatory Flags#

DUNS number
600850213
Device count
500
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540151300121RadTagRadtag Technologies IncKSS2025-12-30
07540151300138RadTagRadtag Technologies IncKSS2025-12-30
07540151300145RadTagRadtag Technologies IncKSS2025-12-30
07540151300152RadTagRadtag Technologies IncKSS2025-12-30
05060242472596ORTHO® Elution KitALBA BIOSCIENCE LIMITEDKSS2025-12-04
09555240405616SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
19555240405613SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
07540151300107AccuTagRadtag Technologies IncKSS2023-11-02
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSS2023-10-13
00810106410333Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410340Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410326Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-04-24
07540151300046RadTagRadtag Technologies IncKSS2022-12-02
07540151300053RadTagRadtag Technologies IncKSS2022-12-02
07540151300060RadTagRadtag Technologies IncKSS2022-12-02
07540151300077RadTagRadtag Technologies IncKSS2022-12-02
07540151300008RadTagRadtag Technologies IncKSS2022-12-01
07540151300015RadTagRadtag Technologies IncKSS2022-12-01
07540151300022RadTagRadtag Technologies IncKSS2022-12-01
07540151300039RadTagRadtag Technologies IncKSS2022-12-01
10812269031254Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031278TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10812269031285TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031240Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
00812269031264Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10810020440536Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
20810020440533Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
04086000860161CompoMat G5 PlusFresenius Kabi AGKSS2022-11-07