FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425501830
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30414-100
Catalog number
30414-100
Device description
"PENROSE DRAIN 12"" X 1"""
Published
2018-10-01
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
20885425501837PackageGS110In Commercial Distribution
50885425501838PackageGS110In Commercial Distribution
10885425501830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088542550183720885425501837
5088542550183850885425501838
1088542550183010885425501830

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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