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
10889483054321AirLife™048004802025-12-18
10889483054338AirLife™079507952025-12-19
10889483229422AirLife™048504852025-12-19
10889483564288BALLARD™22103-522103-52025-11-20
10889483564394BALLARD™22113-522113-52025-11-21
10889483564608BALLARD™227101322710132025-11-24
10889483564646BALLARD™22712183227121832025-11-24
10889483564806BALLARD™2271603-52271603-52025-11-21
10889483564813BALLARD™22716036-522716036-52025-11-21
10889483564905BALLARD™227166-5227166-52025-11-21
10889483564936BALLARD™2276-52276-52025-11-21
10889483567005BALLARD™2271652271652025-11-24
10889483623411BALLARD™22056-522056-52025-11-20
10889483623541BALLARD™2271516-52271516-52025-11-21
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21
10889483564479BALLARD™2260-52260-52025-11-21
10889483564486BALLARD™22606-522606-52025-11-21
10889483564554BALLARD™22703-522703-52025-11-21

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