FDA.reportPublic FDA data

NEOMED*

Primary DI
00350770003542
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
OK-ITS8
Catalog number
OK-ITS8
Device description
Oral Care Kit 8mm Swab 3mL Saline Amp
Published
2022-04-28
Public version status
New
Distribution status
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
PWNBaby care kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWNBaby Care KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770003549PackageGS1100In Commercial Distribution
00350770003542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000354910350770003549
00350770003542003507700035423507700035420350770003542

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770003498NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003504NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003511NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003528NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003535NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003559NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003566NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003495NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003501NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003518NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003525NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003532NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003549NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003556NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003563NEOMED*Avanos Medical, Inc.PWN2022-04-28
00048526007196NubyLUV N' CARE, LTD.PWN2017-03-23
30048526007197NubyLUV N' CARE, LTD.PWN2017-03-23