FDA.reportPublic FDA data

Aqua-Seal

Primary DI
50192253003015
Brand
Aqua-Seal
Company
Cardinal Health 200, LLC
Model
8888571299
Catalog number
8888571299
Device description
Aqua-Seal Chest Drainage Unit Wet Suction
Published
2025-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253003015PackageGS15In Commercial Distribution
10192253003017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300301550192253003015
1019225300301710192253003017

GMDN Terms#

Term, Definition table
TermDefinition
Chest-percussion airway secretion-clearing systemAn assembly of devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient (child to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) applicator with connecting cable and a control unit. The device is portable and operated by a healthcare professional in a medical facility or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956310698CARDINAL HEALTHCardinal Health 200, LLCGCX2026-04-06
10198956435629CARDINAL HEALTHCardinal Health 200, LLCGCX2026-04-06
10198956355477CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
10198956417991CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
10198956375642CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
10198956277939CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
10198956289284CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-12
10198956261808CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10198956252127CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
10198956242098CARDINAL HEALTHCardinal Health 200, LLCGCX2025-10-22
10198956160859CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198956180383CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198459423567MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-21
10198459398063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-07
10198956073883CARDINAL HEALTHCardinal Health 200, LLCGCX2025-07-04
10198956033252CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-12
10198956087279CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-11
10198956097728CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-05
10198956083790CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08