FDA.reportPublic FDA data

AVANOS

Primary DI
10609038132249
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
13224
Catalog number
13224
Device description
MICROCUFF* Subglottic Suctioning Adult Endotracheal Tube
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609038132249PackageGS110In Commercial Distribution
00609038132242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903813224910609038132249
00609038132242006090381322426090381322420609038132242

GMDN Terms#

Term, Definition table
TermDefinition
Cuff-suction endotracheal tubeA hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12.8Millimeter

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
false
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

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
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34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
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