FDA.report

AVANOS

Primary DI
10609038968817
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
96881
Catalog number
12255
Device description
BALLARD* Oral Care Swabs, Individually Wrapped
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

Related Records

Contact Domains

Product Codes

CodeName
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10609038968817PackageGS11000In Commercial Distribution
00609038968810PrimaryGS10
20609038968814Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903896881710609038968817
00609038968810006090389688106090389688100609038968810
2060903896881420609038968814

GMDN Terms

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

Contacts

PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags

DUNS number
079375431
Device count
250
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
false
Sterilization required before use
false

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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
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10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008740EBL20100SG2025-11-28
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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
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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
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10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008750ELL18100TG2025-11-28

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