FDA.reportPublic FDA data

NEOMED*

Primary DI
00350770003498
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
OK-H2O
Catalog number
OK-H2O
Device description
3mL Water 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
00350770003498PrimaryGS10
10350770003495Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770003498003507700034983507700034980350770003498
1035077000349510350770003495

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
100
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
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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