FDA.reportPublic FDA data

AVANOS

Primary DI
10609038474486
Brand
AVANOS
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2
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.

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
false
Premarket exempt
true
HCT/P
false
Kit
false
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
10193494001695PROBLOC* II Insulated Regional Block Needle120008760HN3S-1002025-12-08
10193494001701PROBLOC* II Insulated Regional Block Needle120008761HN3S-1502025-12-08
10193494001718PROBLOC* II Insulated Regional Block Needle120008762HN3S-402025-12-08
10193494001725PROBLOC* II Insulated Regional Block Needle120008763HN3S-802025-12-08
10193494001732PROBLOC* II Insulated Regional block Needle120008753HN1-402025-11-28
10193494001749PROBLOC* II Insulated Regional block Needle120008754HN1-802025-11-28
10193494001756PROBLOC* II Insulated Regional block Needle120008755HN2-402025-11-28
10193494001763PROBLOC* II Insulated Regional block Needle120008756HN2-802025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating Cable120008759EBL18100TGC2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008740EBL20100SG2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008741EBL20100SGC2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008742EBL20150SG2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008743EBL20150SGC2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008744EBL22050SG2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008745EBL22050SGC2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008746ELL18050SGC2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008747ELL18050TG2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008748ELL18050TGC2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008749ELL18100SGC2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008750ELL18100TG2025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800157Adler Instrument CompanyAdler, Inc.JOL2026-05-26
20809160516574Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
40080196035435MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
40080196995555MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
00192896122802Frazier Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-03-10
20809160513856Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
20809160513337MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
00810130207336MSIModern Surgical Instruments LLCJOL2026-01-23
16931918174334AllesetGRI Medical & Electronic Technology Co., Ltd.JOL2026-01-21
50192253039670CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
00840343727178GEN2SURGIX MEDICAL LLCJOL2025-12-11
16974500613491Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
16974500613507Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
57613327680725Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
57613327680732Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680749Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
30889483563414BALLARD™SUNMED, LLCJOL2025-12-01
30889483564978BALLARD™SUNMED, LLCJOL2025-12-01
30889483565319BALLARD™SUNMED, LLCNSB2025-12-01
30889483565333BALLARD™SUNMED, LLCNSB2025-12-01
30889483565340BALLARD™SUNMED, LLCNSB2025-12-01
30889483565357BALLARD™SUNMED, LLCNSB2025-12-01
30889483565364BALLARD™SUNMED, LLCNSB2025-12-01
10889483565377BALLARD™SUNMED, LLCNSB2025-12-01
30889483565388BALLARD™SUNMED, LLCNSB2025-12-01
30889483565562BALLARD™SUNMED, LLCJOL2025-12-01
00840314238511gSourceGSOURCE LLCJOL2025-11-24
00840314238528gSourceGSOURCE LLCJOL2025-11-24
00840314238535gSourceGSOURCE LLCJOL2025-11-24
00840314238542gSourceGSOURCE LLCJOL2025-11-24