FDA.reportPublic FDA data

C.D.RICH

Primary DI
26935238804091
Brand
C.D.RICH
Company
Chengdu Rich Science Industry Co., Ltd.
Model
PA 5cm
Device description
A swab consists of a swab stick and a swab tip. The swab stick is made from ABS. The swab tip is made from polyamide fiber (Nylon) .The product is applicable to the collection of human respiratory tract specimen and mouth mucosa specimen.
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26935238804091PackageGS110000In Commercial Distribution
16935238804094PrimaryGS10
06935238804097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693523880409126935238804091
1693523880409416935238804094
06935238804097069352388040976935238804097

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724353334
Device count
200
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
38053326007027FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391329Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391336Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391343Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391350Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391367Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391374Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391527Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391534Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262392104Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394030Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394047Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394061Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394078Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394085Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394092Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394115Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394122Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394139Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394146Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394153Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394177Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394191Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394207Specimen Collection swabHLB CO.,LTDKXG2025-10-28
08809262394214Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394221Specimen Collection SwabHLB CO.,LTDKXG2025-10-28