FDA.reportPublic FDA data

MDHC

Primary DI
06974669350278
Brand
MDHC
Company
MDHC Life Technologies (Kunshan) Co., LTD.
Model
10 pcs/box
Device description
Reservoir
Published
2023-07-06
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
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974669350278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974669350278069746693502786974669350278

GMDN Terms#

Term, Definition table
TermDefinition
Test tube/reservoir cap IVDA covering intended to be used to seal the top of an in vitro diagnostic test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
625685749
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974669350292MDHC20 pcs/bag2023-07-06
06974669350193MDHC5 pcs2023-07-06
06974669350209MDHC1 pair2023-07-06
06974669350216MDHC1 pcs2023-07-06
06974669350223MDHC10 pcs2023-07-06
06974669350230MDHC1 pcs/box2023-07-06
06974669350247MDHC5 units/case2023-07-06
06974669350254MDHC250 tips/box2023-07-06
06974669350261MDHC5 pcs/bag2023-07-06
06974669350285MDHC5 pcs/bag2023-07-06
06974669350308MDHC1 pcs/bag2023-07-06
06974669350315MDHC6 pcs/box2023-07-06
06974669350322MDHC5 pcs/bag2023-07-06
06974669350339MDHC12 pcs/Case2023-07-06
06974669350346MDHC50 serving/box2023-07-06
06974669350353MDHC1 set/bag2023-07-06
06974669350360MDHC1 set/bag2023-07-06
06974669350377MDHC5 pcs/bag2023-07-06
06974669350384MDHC5 pcs/bag2023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501430BREATHING BAG single use 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501508BREATHING BAG reusable 3000ASSOMEDIKA, OOOBTC2026-05-27
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
10885632455438Halyard Breathing BagAIRLIFEBTC2025-07-25
10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
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