FDA.reportPublic FDA data

C.D.RICH

Primary DI
16935238804148
Brand
C.D.RICH
Company
Chengdu Rich Science Industry Co., Ltd.
Model
Is-I 3ml
Device description
This product is used for the collection, transferring and storage of specimen in labs/hospitals.
Published
2022-12-07
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
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26935238804145PackageGS1800In Commercial Distribution
16935238804148PrimaryGS10
06935238804141Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693523880414526935238804145
1693523880414816935238804148
06935238804141069352388041416935238804141

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Regulatory Flags#

DUNS number
724353334
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16935238804469C.D.RICHIs-stool collector 8ml2022-12-08
16935238804476C.D.RICHIs-stool collector 20ml2022-12-08
16935238804483C.D.RICHIs-stool collector 30ml2022-12-08
16935238804490C.D.RICHIs-stool collector 40ml2022-12-08
16935238804506C.D.RICHIs-stool collector 50ml2022-12-08
16935238804513C.D.RICHIs-stool collector 60ml2022-12-08
16935238804520C.D.RICHIs-stool collector 100ml2022-12-08
16935238804537C.D.RICHIs-stool collector 120ml2022-12-08
16935238804544C.D.RICHIs-saliva collector 8ml2022-12-08
16935238804551C.D.RICHIs-saliva collector 20ml2022-12-08
16935238804568C.D.RICHIs-saliva collector 30ml2022-12-08
16935238804575C.D.RICHIs-saliva collector 40ml2022-12-08
16935238804582C.D.RICHIs-saliva collector 50ml2022-12-08
16935238804278C.D.RICHI 3.5ml2022-12-07
16935238804384C.D.RICHIs-urine collector 8ml2022-12-07
16935238804407C.D.RICHIs-urine collector 30ml2022-12-07
16935238804414C.D.RICHIs-urine collector 40ml2022-12-07
16935238804421C.D.RICHIs-urine collector 50ml2022-12-07
16935238804438C.D.RICHIs-urine collector 60ml2022-12-07
16935238804445C.D.RICHIs-urine collector 100ml2022-12-07

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Primary DI, Brand, Company table
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10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
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10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29
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