FDA.reportPublic FDA data

NeuMoDxTM Biohazard Waste Bag

Primary DI
10814278020663
Brand
NeuMoDxTM Biohazard Waste Bag
Company
Neumodx Molecular, Inc.
Model
600100
Catalog number
600100
Device description
NeuMoDx Biohazard Waste Bag
Published
2019-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814278020663PrimaryGS10
00814278020666Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081427802066310814278020663
00814278020666008142780206668142780206660814278020666

GMDN Terms#

Term, Definition table
TermDefinition
Cytotoxic waste receptacleA device designed as a container to allow the safe deposit, collection and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic drugs). This container consists of a metal and/or hard plastic disposable structure, frequently with a liner or a sealed leak proof bag, and will usually have a lid that allows temporary and final closure options; the lid will typically include a seal to prevent leakage. It will be identified with a cytotoxic biohazard symbol on its labelling. It will be sent to an appropriate waste treatment plant for disposal when filled to the recommended level.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(734)372-2617ewinnega@neumodx.com

Regulatory Flags#

DUNS number
078667309
Device count
5
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814278020014NeuMoDx™ 288 Molecular System5001005001002019-03-29
10814278020724NeuMoDx™ 96 Molecular System5002005002002019-03-29
10814278020861NeuMoDx™ Lysis Buffer 54009004009002021-12-13
10814278021219NeuMoDx™ Lysis Buffer 64017004017002020-03-19
10814278021257NeuMoDx™ Viral Lysis Buffer4016004016002020-03-20
10814278021264NeuMoDx SARS-CoV-2 Test Strip3008003008002020-04-23
10814278021301NeuMoDx™ Vantage Viral Lysis Buffer4015004015002021-12-13
10814278020045NeuMoDxTM GBS Test Strip2004002004002019-04-03
10814278020199NeuMoDxTM LDT Master Mix, DNA2101002101002019-03-29
10814278020205NeuMoDxTM LDT Master Mix, RNA3101003101002019-03-29
10814278020212NeuMoDxTM Wash Reagent4001004001002019-03-29
10814278020229NeuMoDxTM Release Reagent4002004002002019-03-29
10814278020236NeuMoDxTM Lysis Buffer 14004004004002019-03-29
10814278020243NeuMoDxTM Lysis Buffer 24005004005002019-03-29
10814278020250NeuMoDxTM Lysis Buffer 34006004006002019-03-29
10814278020267NeuMoDxTM Lysis Buffer 44007004007002019-03-29
10814278020274NeuMoDxTM Cartridge1001001001002019-03-29
10814278020281NeuMoDxTM Extraction Plate1002001002002019-03-29
10814278020304NeuMoDxTM LDT Probe/Primer Strip1004001004002019-03-29
00814278020864NeuMoDx™ Lysis Buffer 54009004009002021-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08