FDA.report

Stool Specimen Container

Primary DI
00616784423432
Brand
Stool Specimen Container
Company
DYNAREX CORPORATION
Model
4234
Device description
Stool Specimen Container 30mL, Sterile, Individually Wrapped; Polystyrene
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00616784423432PackageGS1100In Commercial Distribution
00616784423418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784423432006167844234326167844234320616784423432
00616784423418006167844234186167844234180616784423418

GMDN Terms

TermDefinition
Faecal specimen container IVD, no additiveA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a faecal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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