FDA.report

Kendall

Primary DI
10192253051674
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
8889207026
Catalog number
8889207026-
Device description
Specimen Container
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253051672PrimaryGS10
10192253051674Unit of UseGS10

GMDN Terms

TermDefinition
Midstream urine specimen container IVDA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume4Fluid Ounce

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16970462546716Broncho SamplerShenzhen HugeMed Medical Technical Development Co., Ltd.FMH2026-02-10
H1084306553CorningCorning IncorporatedFMH2026-01-26
H1083540143Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540173Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540203Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117393CorningCorning IncorporatedFMH2026-01-14
30815112021475Transpec Specimen Radiography DeviceBracco Diagnostics Inc.FMH2026-01-09
30815112021482TranspecBracco Diagnostics Inc.FMH2026-01-09
00810124536923Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyFMH2025-12-05
40198459304638MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
40198459382964MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
20816203023913O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024019TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024095O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024156TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
40080196035299MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40884389226262MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40888277117922MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40198459351328MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
00840165500300Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500324Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500362LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500485LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500508LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500058LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500072StarCLICK 100Starplex Scientific Corp.FMH2025-05-28
00840165500294Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500355LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500393LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500454LeakbusterStarplex Scientific Corp.FMH2025-05-28