FDA.reportPublic FDA data

C.D.RICH

Primary DI
26935238804435
Brand
C.D.RICH
Company
Chengdu Rich Science Industry Co., Ltd.
Model
Is-urine collector 60ml
Device description
It is used for collection, transportation, storage and treatment of body fluid specimen, include stool,urine,sputum,Pathological effusion etc.
Published
2022-12-07
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
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26935238804435PackageGS1500In Commercial Distribution
16935238804438PrimaryGS10
06935238804431Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693523880443526935238804435
1693523880443816935238804438
06935238804431069352388044316935238804431

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724353334
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B645T0466EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0486EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0749EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0759EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B6451B265EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6451R007EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645GB477EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0006EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0246EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6452P195EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P145EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P459EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645GB285EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0448EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0487EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
10382902212611BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
16972698600408KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
18053326001021BHI BROTHCOPAN ITALIA SPAJSG2023-03-03
00848838002878REMELREMEL, INC.JSG2022-12-23
00848838002946REMELREMEL, INC.JSG2022-12-23
00848838002960REMELREMEL, INC.JSG2022-12-23
00848838003363REMELREMEL, INC.JSG2022-12-23
00848838003394REMELREMEL, INC.JSG2022-12-23
00848838003721REMELREMEL, INC.JSG2022-12-23
00848838003912REMELREMEL, INC.JSG2022-12-23
00848838004537REMELREMEL, INC.JSG2022-12-23
00848838004575REMELREMEL, INC.JSG2022-12-23
00848838004612REMELREMEL, INC.JSG2022-12-23