FDA.reportPublic FDA data

Medline

Primary DI
10884389141595
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS876630
Catalog number
MDS876630
Device description
KIT, SETUP, YNK, SCT HNDL, YCON
Published
2020-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXZDental hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXZDental Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389141596PackageGS160In Commercial Distribution
10884389141595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438914159640884389141596
1088438914159510884389141595

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, single-useA collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06956748709443Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXZ2026-02-04
B23931150Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
B23931151Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
00850035489055Oral Relief KitzOrthonu LLCNXZ2025-04-27
B23930870Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23930871Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23931080Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931081Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931060Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931070Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931061Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931071Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23930020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931050Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931051Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930900Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931040Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23930901Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931041Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931030Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23931031Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23930730Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930940Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930950Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930731Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930941Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930951Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17