FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380061493
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SU130-1305
Catalog number
SU130-1305
Device description
JACKSON-PRATT 100CC BULB RESERVOIR
Published
2018-05-10
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

Product Codes#

Code, Name table
CodeName
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380061490PackageGS110In Commercial Distribution
50885380061491PackageGS13In Commercial Distribution
10885380061493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538006149020885380061490
5088538006149150885380061491
1088538006149310885380061493

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
00630094061504Bioseal Inc.BIOSEALGCY2024-01-29
00630094061511Bioseal Inc.BIOSEALGCY2024-01-29
00630094061528Bioseal Inc.BIOSEALGCY2024-01-29
00630094049175Bioseal Inc.BIOSEALGCY2024-01-25
10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
00630094049052Bioseal Inc.BIOSEALGCY2024-01-24
00630094049168Bioseal Inc.BIOSEALGCY2024-01-24
00630094043807Bioseal Inc.BIOSEALGCY2024-01-19
00630094043814Bioseal Inc.BIOSEALGCY2024-01-19
00630094192222Bioseal Inc.BIOSEALGCY2023-12-07
00630094196800Bioseal Inc.BIOSEALGCY2023-11-29
00630094196817Bioseal Inc.BIOSEALGCY2023-11-29
00630094196824Bioseal Inc.BIOSEALGCY2023-11-29
00630094196831Bioseal Inc.BIOSEALGCY2023-11-29
00630094196855Bioseal Inc.BIOSEALGCY2023-11-29
00630094196862Bioseal Inc.BIOSEALGCY2023-11-29
00630094196879Bioseal Inc.BIOSEALGCY2023-11-29
00630094196909Bioseal Inc.BIOSEALGCY2023-11-29
00630094196916Bioseal Inc.BIOSEALGCY2023-11-29
00630094196954Bioseal Inc.BIOSEALGCY2023-11-29
00630094196961Bioseal Inc.BIOSEALGCY2023-11-29
00630094196985Bioseal Inc.BIOSEALGCY2023-11-29
00630094197005Bioseal Inc.BIOSEALGCY2023-11-29