FDA.reportPublic FDA data

NEOMED*

Primary DI
10350770003532
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
OK-ITS6
Catalog number
OK-ITS6
Device description
Oral Care Kit 6mm 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
OTC
false
Sterile
false
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
10350770003532PackageGS1100In Commercial Distribution
00350770003535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000353210350770003532
00350770003535003507700035353507700035350350770003535

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

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014360644-242026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014370645-142026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1200014380645-202026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULL1200014390645-242026-10-14
00350770997957MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095831020645-142026-10-14
00193493000753GenVisc 850 Sodium Hyaluronate50653-0006-0150653-0006-012024-03-06
00193493000760TriVisc Sodium Hyaluronate50653-0006-0450653-0006-042024-03-06
00850653006016GenVisc® 850 sodium hyaluronate50653-0006-012016-10-31
00850653006047TriVisc™ sodium hyaluronate50653-0006-042018-12-20
10680651467185Halyard46718N589132017-12-21

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
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
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