FDA.reportPublic FDA data

Sterile Specimen Container

Primary DI
17503025060184
Brand
Sterile Specimen Container
Company
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.
Model
070020
Device description
120ML MIDSTREAM KIT STNO FUNNL
Published
2018-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
37503025060188PackageGS11Not in Commercial Distribution
57503025060182PackageGS1100Not in Commercial Distribution
17503025060184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3750302506018837503025060188
5750302506018257503025060182
1750302506018417503025060184

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
Radiation Sterilization

Regulatory Flags#

DUNS number
813622313
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17503025060009Sterile Specimen Container0100012018-09-09
17503025060016Sterile Specimen Container0100022018-09-09
17503025060023Sterile Specimen Container0100382018-09-09
17503025060030Sterile Specimen Container0200162018-09-09
17503025060047Sterile Specimen Container0200382018-09-09
17503025060054Sterile Specimen Container0200392018-09-09
17503025060061Sterile Specimen Container0202142018-09-09
17503025060078Sterile Specimen Container0210162018-09-09
17503025060092Sterile Specimen Container0210902018-09-09
17503025060108Sterile Specimen Container0300062018-09-09
17503025060115Sterile Specimen Container0300072018-09-09
17503025060122Sterile Specimen Container0300082018-09-09
17503025060191Sterile Specimen Container226101312018-09-09
17503025060306Samco Clicktainer90WHT53-10022018-09-09
17503025060085Sterile Specimen Container0210382018-09-09
17503025060139Sterile Specimen Container0700002018-11-08
17503025060146Sterile Specimen Container0700012018-09-09
17503025060153Sterile Specimen Container0700022018-09-09
17503025060160Sterile Specimen Container0700062018-11-08
17503025060177Sterile Specimen Container0700102018-09-09

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