FDA.reportPublic FDA data

BALLARD™

Primary DI
10889483563465
Brand
BALLARD™
Company
SUNMED, LLC
Model
143
Catalog number
143
Device description
BALLARD™ MINI-BAL SAMPLING CATHETER
Published
2025-11-17
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
30889483563469PackageGS15In Commercial Distribution
00609038111193PreviousGS10
10889483563465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088948356346930889483563469
00609038111193006090381111936090381111930609038111193
1088948356346510889483563465

GMDN Terms#

Term, Definition table
TermDefinition
Lung secretion sampling catheterA flexible tubular device designed to be introduced into a lung, via the upper airway and past the primary bronchus, to obtain a sample of lung mucus secretion by syringe suction for the diagnosis of lung infection (typically ventilator-associated pneumonia). The distal tip is shielded with a bioabsorbable polymer sheath designed to degrade following insertion and intended to protect the tip from microbial contamination as it passes through the airway to the sampling site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge13French

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483564523BALLARD™227013522701352025-11-19
10889483564585BALLARD™22705227052025-11-18
10889483564615BALLARD™227101-5227101-52025-11-20
10889483564622BALLARD™2271018-52271018-52025-11-20
10889483564653BALLARD™2271218-52271218-52025-11-20
10889483564721BALLARD™22714183-522714183-52025-11-20
10889483564738BALLARD™2271418-52271418-52025-11-20
10889483564837BALLARD™2271613-52271613-52025-11-20
10889483564844BALLARD™227161-5227161-52025-11-20
10889483564868BALLARD™2271618-52271618-52025-11-20
10889483623527BALLARD™2271053-52271053-52025-11-20
10889483623534BALLARD™227105-5227105-52025-11-20
10889483623589BALLARD™2271616-52271616-52025-11-20
10889483564769BALLARD™22714186-522714186-52025-11-19
10889483564134BALLARD™216-5216-52026-07-09
10889483563113BALLARD™11000110002025-12-01
10889483007051SunMed9-0207-019-0207-012024-03-12
10889483007068SunMed9-0207-039-0207-032024-03-12
10889483564325BALLARD™2210-52210-52025-11-20
10889483623411BALLARD™22056-522056-52025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483563458BALLARD™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
10609038111398AVANOSAvanos Medical, Inc.OYI2020-06-24
00841523144426Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.OYI2019-07-10