FDA.reportPublic FDA data

BALLARD™

Primary DI
10889483564523
Brand
BALLARD™
Company
SUNMED, LLC
Model
2270135
Catalog number
2270135
Device description
BALLARD™ TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, T-Piece, Tracheostomy
Published
2025-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483564520PackageGS110In Commercial Distribution
30889483564527PackageGS12In Commercial Distribution
00609038947013PreviousGS10
10889483564523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088948356452020889483564520
3088948356452730889483564527
00609038947013006090389470136090389470130609038947013
1088948356452310889483564523

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
069009268
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
false
Expiration date on label
false
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
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
10889483221747AirLife™026202622025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874954611Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874957667Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874958459Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, Y-Adaptor, InfantDynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-25
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, PediatricDynarex CorporationBSY2026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344266Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344747Resp-O2 Closed Suction Tracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-18
00840117344754Resp-O2 Closed Suction Tracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-18
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
00840117344136Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-01-05
00840117344143Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-01-05
00840117344167Resp-O2 Vexta72 Closed Suction Tracheal CatheterDynarex CorporationBSY2026-01-05
00840117344174Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05
00840117344181Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05
10889483564325BALLARD™SUNMED, LLCBSY2025-11-20
10889483564615BALLARD™SUNMED, LLCBSY2025-11-20
10889483564622BALLARD™SUNMED, LLCBSY2025-11-20
10889483564653BALLARD™SUNMED, LLCBSY2025-11-20
10889483564721BALLARD™SUNMED, LLCBSY2025-11-20
10889483564738BALLARD™SUNMED, LLCBSY2025-11-20
10889483564837BALLARD™SUNMED, LLCBSY2025-11-20
10889483564844BALLARD™SUNMED, LLCBSY2025-11-20