FDA.reportPublic FDA data

AVANOS

Primary DI
10609038111398
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
11139
Catalog number
142
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
10609038111398PackageGS15In Commercial Distribution
00609038111391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903811139810609038111398
00609038111391006090381113916090381113910609038111391

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 Gauge16French

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
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

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
10609038111190AVANOSAvanos Medical, Inc.OYI2020-06-24
00841523144426Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OYI2019-07-10