FDA.reportPublic FDA data

AVANOS

Primary DI
10609038111190
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
11119
Catalog number
143
Device description
BALLARD* Mini-BAL Sampling Catheter
Published
2020-06-24
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
OYINon-bronchoscopic bronchoalveolar lavage catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYINon-Bronchoscopic Bronchoalveolar Lavage CatheterAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609038111190PackageGS15In Commercial Distribution
00609038111193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903811119010609038111190
00609038111193006090381111936090381111930609038111193

GMDN Terms#

Term, Definition table
TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge13French

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
true
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
10889483563458BALLARD™SUNMED, LLCOYI2025-11-17
10889483563465BALLARD™SUNMED, LLCOYI2025-11-17
30889483563452BALLARD™SUNMED, LLCOYI2025-11-17
30889483563469BALLARD™SUNMED, LLCOYI2025-11-17
06936881156663Jet Lavage CatheterWell Lead Medical Co.,LtdOYI2022-12-08
06936881156670Jet Lavage CatheterWell Lead Medical Co.,LtdOYI2022-12-08
06936881156687Jet Lavage CatheterWell Lead Medical Co.,LtdOYI2022-12-08
06936881156694Jet Lavage CatheterWell Lead Medical Co.,LtdOYI2022-12-08
06936881156700Jet Lavage CatheterWell Lead Medical Co.,LtdOYI2022-12-08
06936881156717Jet Lavage CatheterWell Lead Medical Co.,LtdOYI2022-12-08
00609038111193Ballard* Mini-BAL Sampling CatheterAvanos Medical, Inc.OYI2020-06-24
00609038111391Ballard* Mini-BAL Sampling CatheterAvanos Medical, Inc.OYI2020-06-24
10609038111398AVANOSAvanos Medical, Inc.OYI2020-06-24
00841523144426Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OYI2019-07-10