FDA.reportPublic FDA data

C.D.RICH

Primary DI
16935238804278
Brand
C.D.RICH
Company
Chengdu Rich Science Industry Co., Ltd.
Model
I 3.5ml
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
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26935238804275PackageGS1800In Commercial Distribution
16935238804278PrimaryGS10
06935238804271Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693523880427526935238804275
1693523880427816935238804278
06935238804271069352388042716935238804271

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
16935238804148C.D.RICHIs-I 3ml2022-12-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500581LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
10840165401406LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
00840117333420LabChoice Specimen Bags with Pouch, 4" x 6" (10.2 cm x 15.2 cm), 1.8 milDynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
10840165400966Starplex Pretium Canada Packaging ULCNNI2025-03-04