FDA.reportPublic FDA data

HARETA

Primary DI
16975800988609
Brand
HARETA
Company
Yancheng Jingwei Chemicals Co., Ltd
Model
PTRP001L-NS
Device description
TRANSFER PIPETTE 1ML 500PCS/BOX AND 5000PCS/CASE
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
16975800988609PackageGS1500In Commercial Distribution
06975800988602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697580098860916975800988609
06975800988602069758009886026975800988602

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

Regulatory Flags#

DUNS number
546094272
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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