FDA.reportPublic FDA data

Ballard* Mini-BAL Sampling Catheter

Primary DI
00609038111391
Brand
Ballard* Mini-BAL Sampling Catheter
Company
Avanos Medical, Inc.
Model
11139
Catalog number
142
Device description
BALLARD* Mini-BAL Sampling Catheter
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
Tracheobronchial suction/insufflation catheter, dual-lumenA sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a dual-lumen tube which allows simultaneous suction and insufflation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Premarket exempt
true
Lot or batch
true

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
10609038111190AVANOSAvanos Medical, Inc.OYI2020-06-24
10609038111398AVANOSAvanos Medical, Inc.OYI2020-06-24
00841523144426Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OYI2019-07-10