FDA.reportPublic FDA data

MediChoice

Primary DI
10885632133152
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
SPC405OR
Device description
Container Specimen 90 Milliliter With Patient Label Tamper-Evident Seal Leak-Proof Wide Mouth Orange Lid Sterile In Operating Room Peel Pouch Pneumatic Tube Approved Single Patient Use Not Made With Natural Rubber Latex MediChoice
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632133150PackageGS1100In Commercial Distribution
10885632133152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563213315050885632133150
1088563213315210885632133152

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, sterileA sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05
10885632522659SurgiTrackSM4501306C1C2026-06-05
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
10198459319990Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-04-18
10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10198459295270Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-16
10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29