FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439772418
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11JUMDA
Catalog number
SBA11JUMDA
Device description
JUGULAR DRAPE KIT
Published
2020-05-11
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
ERYDrape, surgical, ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERYDrape, Surgical, EntGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439772416PackageGS15In Commercial Distribution
10888439772418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843977241650888439772416
1088843977241810888439772418

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
Expiration date on label
true
No 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
50885380189881CONVERTORSCardinal Health 200, LLCERY2024-02-28
10885380189883CONVERTORSCardinal Health 200, LLCERY2024-02-28
10195594968304CARDINAL HEALTHCardinal Health 200, LLCERY2021-04-15
50195594968302CARDINAL HEALTHCardinal Health 200, LLCERY2021-04-15
00860005664009Isolaer Aerosol Isolation BarrierInquis Medical, Inc.ERY2021-02-03
10192253038422CONVERTORSCardinal Health 200, LLCERY2020-11-18
50192253038420CONVERTORSCardinal Health 200, LLCERY2020-11-18
10888439905557CARDINAL HEALTHCardinal Health 200, LLCERY2020-10-12
50888439905555CARDINAL HEALTHCardinal Health 200, LLCERY2020-10-12
50888439772416CARDINAL HEALTHCardinal Health 200, LLCERY2020-05-11
10888439793840CARDINAL HEALTHCardinal Health 200, LLCERY2020-04-08
50888439793848CARDINAL HEALTHCardinal Health 200, LLCERY2020-04-08
50885380176416CONVERTORSCardinal Health 200, LLCERY2019-12-13
50885380133549CONVERTORSCardinal Health 200, LLCERY2019-09-24
10888439381313CARDINAL HEALTHCardinal Health 200, LLCERY2019-03-12
50888439381311CARDINAL HEALTHCardinal Health 200, LLCERY2019-03-12
50885380169289CARDINAL HEALTHCardinal Health 200, LLCERY2019-01-22
50885380164406CARDINAL HEALTHCardinal Health 200, LLCERY2018-11-28
50885380161016CONVERTORSCardinal Health 200, LLCERY2018-03-01
50885380160538CONVERTORSCardinal Health 200, LLCERY2018-02-08
10885380117886CONVERTORSCardinal Health 200, LLCERY2018-01-17
50885380117884CONVERTORSCardinal Health 200, LLCERY2018-01-17
10885380138997CONVERTORSCardinal Health 200, LLCERY2017-11-07
10885380141515CONVERTORSCardinal Health 200, LLCERY2017-09-28
50885380139008CONVERTORSCardinal Health 200, LLCERY2017-09-28
50885380140493CONVERTORSCardinal Health 200, LLCERY2017-09-28
50885380152618CONVERTORSCardinal Health 200, LLCERY2017-07-24
00854427007124HEPRO. US General Pack - 10 Pouches-CaseHEPRO.US INC.ERY2017-06-21
00854427007988HEPRO.US Welcome Pack - CaseHEPRO.US INC.ERY2017-06-21
00854427007070HEPRO.US Surgical Scrub Suit 50pcs per CaseHEPRO.US INC.ERY2017-06-20