FDA.reportPublic FDA data

HARETA

Primary DI
06975800988640
Brand
HARETA
Company
Yancheng Jingwei Chemicals Co., Ltd
Model
PTRP001L-STR
Device description
TRANSFER PIPETTE 1ML STERILE 500PCS/BOX AND 2000PCS/CASE
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975800988647PackageGS1500In Commercial Distribution
06975800988640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697580098864716975800988647
06975800988640069758009886406975800988640

GMDN Terms#

Term, Definition table
TermDefinition
Plasma filtration/collection kit IVDA collection of devices intended to be used for the separation through filtration and collection of plasma from a whole blood specimen for subsequent in vitro diagnostic investigation. It typically consists of a contained or encased selectively-permeable membrane, which filters the whole blood to isolate the plasma component, and additional devices for plasma collection, transfer, containment and/or transportation (e.g., syringe, collection tube, pipette tip). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
546094272
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975800983942NO MARKPL90-PL2023-01-28
06975800983959NO MARKPL90-WH2023-01-28
06975800983935CANCERAF2575-PL2023-01-06
06975800983010TANNERTNR DFROST902022-12-14
06975800983027TANNERTNR DFROST90CC2022-12-14
06975800983034TANNERTNR DFROST90AD2022-12-14
06975800983041TANNERTNR DFROST90ADCC2022-12-14
06975800983058TANNERTNR DFROST452022-12-14
06975800983065TANNERTNR DFROST45AD2022-12-14
06975800983072TANNERTNR WHT902022-12-14
06975800983089TANNERTNR WHT90CC2022-12-14
06975800983096TANNERTNR WHT90AD2022-12-14
06975800983102TANNERTNR WHT90ADCC2022-12-14
06975800983119TANNERTNR WHT452022-12-14
06975800983126TANNERTNR WHT45AD2022-12-14
06975800983133TANNERTNR WHT90NM2022-12-14
06975800983140TANNERTNR WHT90CCNM2022-12-14
06975800983157TANNERTNR WHT90NMAD2022-12-14
06975800983164TANNERTNR WHT90CCNMAD2022-12-14
06975800983171TANNERTNR WHT45NM2022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975582544010CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544027CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544034CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544041CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544058CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00667259004007Laguna Edge (2M)Silhouet-Tone CorporationLGX2025-11-12
00728564057000Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
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00728564060000Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
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00728564065012Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
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00728564068013Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
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00728564157014Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158004Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10