FDA.reportPublic FDA data

NEOMED*

Primary DI
00350770003559
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
OK-SAL
Catalog number
OK-SAL
Device description
3mL Saline Ampules
Published
2022-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00350770003559PrimaryGS10
10350770003556Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770003559003507700035593507700035590350770003559
1035077000355610350770003556

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
150
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
00350770003542NEOMED*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