FDA.reportPublic FDA data

CHS

Primary DI
00628725096650
Brand
CHS
Company
Stadco PolyProducts Inc
Model
S6001
Catalog number
S6001
Device description
SPECIMEN HAT BLACK GRADUATIONS
Published
2023-07-06
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

Contact Domains#

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
50628725096655PrimaryGS10
00628725096650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509665550628725096655
00628725096650006287250966506287250966500628725096650

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9058259300regulatory.affairs@chsltd.com

Regulatory Flags#

DUNS number
247651813
Device count
50
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725096339CHSEM1001-1EM1001-12023-07-07
00628725096414CHSEM1001EM10012023-07-06
00628725096438CHSEM1001-GREYEM1001-GREY2023-07-06
00628725096445CHSEM1001-MEM1001-M2023-07-06
00628725096452CHSEM1002EM10022023-07-06
00628725096469CHSEM1002-MEM1002-M2023-07-06
00628725096476CHSEM1002-TURQEM1002-TURQ2023-07-06
00628725096483CHSEM1003EM10032023-07-06
00628725096490CHSRAB1009RAB10092023-07-06
00628725096506CHSRB1008RB10082023-07-06
00628725096513CHSS2002S20022023-07-06
00628725096520CHSS2007S20072023-07-06
00628725096537CHSS2008S20082023-07-06
00628725096544CHSS2009S20092023-07-06
00628725096551CHSS2011-CLS2011-CL2023-07-06
00628725096568CHSS2011-MS2011-M2023-07-06
00628725096575CHSS2012S20122023-07-06
00628725096582CHSS2012-GS2012-G2023-07-06
00628725096599CHSS2012-MS2012-M2023-07-06
00628725096605CHSS3000 PPS3000 PP2023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008090Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-09
10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
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