FDA.reportPublic FDA data

Ballard* Assisted Care 24-Hour Oral Care Kit

Primary DI
00609038474489
Brand
Ballard* Assisted Care 24-Hour Oral Care Kit
Company
Avanos Medical, Inc.
Model
47448
Catalog number
970600
Device description
AVANOS* Assisted Care 24-Hour Oral Care Kit
Published
2020-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609038474486PackageGS120In Commercial Distribution
00609038474489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903847448610609038474486
00609038474489006090384744896090384744890609038474489

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(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Premarket exempt
true
Lot or batch
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10809160513330MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
20809160513337MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
07613327680720Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680732Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680749Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
10889483565315BALLARD™SUNMED, LLCNSB2025-12-01
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10889483565384BALLARD™SUNMED, LLCNSB2025-12-01
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00661392004580LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392004733LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012059LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012066LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012097LSL HEALTHCARELSL Industries, LLCNSB2025-10-30