FDA.reportPublic FDA data

AVANOS

Primary DI
10609038352166
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
35216
Catalog number
35216
Device description
MICROCUFF* Adult Endotracheal Tube
Published
2020-04-01
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
10609038352166PackageGS110In Commercial Distribution
00609038352169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903835216610609038352166
00609038352169006090383521696090383521690609038352169

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10.8Millimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344104659MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104666MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104673MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104680MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104697MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104703MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104710MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104727MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104734MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104741MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104758MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104765MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104772MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104789MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104796MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104802MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104819MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104826MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104833MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104840MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104857MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104864MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104871MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104888MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104895MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104901MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10190752147799Vital Signs™AIRLIFEBTR2021-06-14
10190752147751Vital Signs™AIRLIFEBTR2021-04-09
10190752147768Vital Signs™AIRLIFEBTR2021-04-09
10190752147775Vital Signs™AIRLIFEBTR2021-04-09