FDA.reportPublic FDA data

Gongdong

Primary DI
06947462491684
Brand
Gongdong
Company
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
Model
G1036
Device description
TEST TUBE, 16x85, PP, 9ml
Published
2022-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947462491684PrimaryGS10
86947462491680Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947462491684069474624916846947462491684
8694746249168086947462491680

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-useA container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Regulatory Flags#

DUNS number
529309049
Device count
3000
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947462435855Gongdong3GALSCR-03G2026-04-21
06947462435862Gongdong1GALSCR-01G2026-04-21
06947462435879Gongdong1QTSCR-01Q2026-04-21
06947462400419Gongdong21022023-03-28
06947462430201GongdongQ115A2024-04-07
06947462430218GongdongQ117A2024-04-07
06947462430225GongdongQ118A2024-04-07
06947462430232GongdongQ119A2024-04-07
06947462430249GongdongQ120A2024-04-07
06947462430256GongdongQ121A2024-04-07
06947462405322GongdongGD5334T12023-11-09
86947462405328GongdongGD5334T12023-11-09
06947462400198GongdongG10462022-08-04
06947462400259GongdongG103012022-08-04
06947462400426GongdongC10262022-08-04
06947462400433GongdongC10252022-08-04
06947462491660GongdongG10302022-08-04
16947462492817GongdongGD100UB2023-09-13
16947462494279GongdongGD040UBW2023-09-13
16947462494286GongdongGD070UB2023-09-13

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Primary DI, Brand, Company table
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00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
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00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
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00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
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20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18