FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594968304
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA18DPFHA
Catalog number
SBA18DPFHA
Device description
JUGULAR DRAPE PACK
Published
2021-04-15
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
50195594968302PackageGS15In Commercial Distribution
10195594968304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559496830250195594968302
1019559496830410195594968304

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
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
50885380189881CONVERTORSCardinal Health 200, LLCERY2024-02-28
10885380189883CONVERTORSCardinal Health 200, LLCERY2024-02-28
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
10888439772418CARDINAL HEALTHCardinal Health 200, LLCERY2020-05-11
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