FDA.reportPublic FDA data

Monoject

Primary DI
50192253005538
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8550B
Catalog number
8550B
Device description
MONOJECT™ GLOVE BOX WITH MOUNTING BRACKET
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KMNCHAIR AND TABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMNChair And Table, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253005538PackageGS15In Commercial Distribution
10192253005530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300553850192253005538
1019225300553010192253005530

GMDN Terms#

Term, Definition table
TermDefinition
Instrument storage cabinetA furniture-like device designed for general-purpose use, typically where surgery is practised and carried out, to store and possibly display surgical instruments and other devices/products which will be used during surgical examinations/procedures. It will typically consist of double doors with glass windows in them that close off the shelving, and multiple drawers where the instruments are kept. It can be made of stainless steel, plastic materials, glass and wood. This device will typically be used in operating and procedure rooms, including dental, ophthalmological clinics, and doctors surgeries.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974847962736JEDHebei Jiede Medical Equipment Co., Ltd.KMN2026-06-04
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionADEPT MEDICAL LIMITEDKMN2026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowADEPT MEDICAL LIMITEDKMN2026-02-09
06973134775172silverfoxSilverfox Corporation LimitedKMN2026-02-05
06970006390105DAYANGGuangdong Dayang Medical Technology Co.,LtdKMN2025-11-20
06974665668216SCIANYongkang Youha Electric Appliance Co.,LtdKMN2025-09-10
06974665668384SCIANYongkang Youha Electric Appliance Co.,LtdKMN2025-09-10
00860014524400MP SeatingMP SEATING INCKMN2025-08-19
00860014524417MP SeatingMP SEATING INCKMN2025-08-19
06973134775165silverfoxSilverfox Corporation LimitedKMN2025-07-09
B845CBZ0411WOTUREIntco Medical Industries, Inc.KMN2025-03-28
B845CBZ0413WOTUREIntco Medical Industries, Inc.KMN2025-03-28
09421905187749Adept Medical Retrograde IR Platform - NarrowADEPT MEDICAL LIMITEDKMN2025-03-21
B845CBZ041WOTUREIntco Medical Industries, Inc.KMN2025-03-20
00854798000380Changing TablePIVOTAL HEALTH SOLUTIONS, INC.KMN2025-03-07
00854798000410Changing TablePIVOTAL HEALTH SOLUTIONS, INC.KMN2025-03-07
00815067013395PROBASICSDrive Devilbiss HealthcareKMN2025-01-20
G53312170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53312370La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53313170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53313370La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53320420La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53320470La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321250La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321270La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321420La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321470La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53332170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53333170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53342170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21