FDA.reportPublic FDA data

Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box

Primary DI
30850016060465
Brand
Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box
Company
Nalge Nunc International Corporation
Model
020214
Device description
90ML/48 SPCWLB,ORCAP,DSPNSR,ST
Published
2022-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
30850016060465PackageGS1400In Commercial Distribution
10850016060461PrimaryGS10
80850016060460Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085001606046530850016060465
1085001606046110850016060461
8085001606046080850016060460

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
080844844
Device count
75
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850016058390Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Racked3742202022-07-22
10850016058628Nalgene™ System 100™ Cryogenic Tube, 1.5 mL externally-threaded5000-10202022-07-26
10850016058581Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded5000-00122022-06-11
10850016058611Nalgene™ System 100™ Cryogenic Tube, 1 mL externally-threaded5000-10122022-07-26
10850016058406Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Coded-rack374220-BR2022-07-22
10850016058468Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Non-2D, Coded-rack374222-BR2022-07-20
10850016058680Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded5012-00122022-08-08
10850016058505Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D3742592022-07-25
10850016058499Nunc™ Cryobank™ Vial, 2 mL internally-threaded3742582022-07-20
10850016058437Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Coded-rack374221-BR2022-07-22
10850016058529Nunc™ Cryobank™ Vial, 5 mL internally-threaded3742612022-07-25
10850016058697Nalgene™ Cryogenic Tube, 2 mL externally-threaded5012-00202022-08-08
10850016058420Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Racked3742212022-07-22
10850016058482Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D, Coded-rack374223-BR2022-07-29
10850016058475Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D, Racked3742232022-07-20
10850016058451Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Non-2D, Racked3742222022-07-20
10850016058666Nalgene™ System 100™ Cryogenic Tube, 1.5 mL externally-threaded, Barcoded5001-10202022-08-08
10850016058598Nalgene™ Cryogenic Tube, 2 mL externally-threaded5000-00202022-06-11
10850016058659Nalgene™ Cryogenic Tube, 5 mL externally-threaded, Barcoded5001-00502022-08-08
10850016058413Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Lock-rack374220LOCK2022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H1084316251CorningCorning IncorporatedFMH2024-10-29