FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380019812
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
4380C
Catalog number
4380C
Device description
COMFORT HOOD -75 EA/BX
Published
2018-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXYHOOD, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXYHood, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380019812PackageGS16In Commercial Distribution
20885380019811PrimaryGS10
10885380019814Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538001981250885380019812
2088538001981120885380019811
1088538001981410885380019814

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hoodA non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
75
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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09009607815001ViVi PEEL-OFF HOODTHI Total Healthcare Innovation GmbHFXY2025-06-10
19009607815008ViVi PEEL-OFF HOODTHI Total Healthcare Innovation GmbHFXY2025-06-10
07613327625172Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
07613327625189Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
07613327625233Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625173Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625180Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625234Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
09009607801004ViVi HelmetTHI Total Healthcare Innovation GmbHFXY2023-11-10
09009607801301ViVi Helmet HPLTHI Total Healthcare Innovation GmbHFXY2023-11-10
09009607812000ViVi HoodTHI Total Healthcare Innovation GmbHFXY2023-11-10
07613327465860T7STRYKER CORPORATIONFXY2020-05-11
07613327465884T7PlusSTRYKER CORPORATIONFXY2020-05-11
07613327465891T7PlusSTRYKER CORPORATIONFXY2020-05-11
07613327466683T7STRYKER CORPORATIONFXY2020-05-11
07613327466706T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327465861T7STRYKER CORPORATIONFXY2020-05-11
37613327465885T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327465892T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327466684T7STRYKER CORPORATIONFXY2020-05-11
37613327466707T7PlusSTRYKER CORPORATIONFXY2020-05-11
50192253018774CARDINAL HEALTHCardinal Health 200, LLCFXY2019-06-26
50192253018781CARDINAL HEALTHCardinal Health 200, LLCFXY2019-06-26
20885380019811CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
50630140927162CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
07613252661078Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
07613252661085Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661079Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661086Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23