LabChoice Pet Cell Bottle, 500 mL

GUDID 00840117337374

Dynarex Corporation

General specimen container IVD, no additive/medium
Primary Device ID00840117337374
NIH Device Record Keyf75a11b4-f350-4b44-95d7-b63f2e2c0015
Commercial Distribution StatusIn Commercial Distribution
Brand NameLabChoice Pet Cell Bottle, 500 mL
Version Model Number43151
Company DUNS008124539
Company NameDynarex Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117329560 [Package]
Package: Case [100 Units]
In Commercial Distribution
GS100840117337374 [Primary]

FDA Product Code

NNIContainer, Specimen, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-24
Device Publish Date2025-06-16

Devices Manufactured by Dynarex Corporation

00616784040028 - Ridgewood Collection Home Care Bed Full Electric 2025-06-24 Catalog Number: 10400 KIT: 1 SET OF BOARDS (BOX 2 OF 2)
00616784040127 - Ridgewood Collection Home Care Bed, Semi-Electric 2025-06-24 Catalog Number: 10401 Kit: 1 SET OF BOARDS (BOX 2 OF 2)
00810180842198 - LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile 2025-06-24 Sterile-EO
00810180842204 - LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm 2025-06-24 Sterile-EO
00810180842211 - LabChoice Sputum Containers, 40 mL 2025-06-24 Non-Sterile
00810180842228 - DispoSafety Biohazard Bags, 39" x 33", 2 MIL, 33 Gallon2025-06-24
00810180842235 - DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 Gallon2025-06-24
00810180842242 - DispoSafety Biohazard Bags, 40" x 46", 3 MIL, 45 Gallon2025-06-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.