FDA.reportPublic FDA data

ViVi Helmet

Primary DI
09009607801004
Brand
ViVi Helmet
Company
THI Total Healthcare Innovation GmbH
Model
80100
Catalog number
80100
Published
2023-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
09009607801004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09009607801004090096078010049009607801004

GMDN Terms#

Term, Definition table
TermDefinition
Surgical helmet systemA system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-858-822-9433vincebates@ivysurgical.com

Regulatory Flags#

DUNS number
300188850
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09009607811003ViVi® HELMET2581100811002025-11-10
09009607811010ViVi® HELMET25 XL81100XL81100XL2025-11-10
09009607811300ViVi® HELMET25 HPL81130811302025-11-10
09009607811317ViVi® HELMET25 XL HPL81130XL81130XL2025-11-10
09009607822207ViVi TOGA Premium Size XL-XXL82220822202025-06-13
09009607822214ViVi TOGA Premium Size M-L82221822212025-06-13
09009607822221ViVi TOGA Premium Size XXS-S82222822222025-06-13
09009607832206ViVi TOGA Premium Size XL-XXL82220V82220V2025-06-13
09009607832213ViVi TOGA Premium Size M-L82221V82221V2025-06-13
09009607832220ViVi TOGA Premium Size XXS-S82222V82222V2025-06-13
19009607822204ViVi TOGA Premium Size XL-XXL82220822202025-06-13
19009607822211ViVi TOGA Premium Size M-L82221822212025-06-13
19009607822228ViVi TOGA Premium Size XXS-S82222822222025-06-13
19009607832203ViVi TOGA Premium Size XL-XXL82220V82220V2025-06-13
19009607832210ViVi TOGA Premium Size M-L82221V82221V2025-06-13
19009607832227ViVi TOGA Premium Size XXS-S82222V82222V2025-06-13
09009607815001ViVi PEEL-OFF HOOD80500V80500V2025-06-10
19009607815008ViVi PEEL-OFF HOOD80500V80500V2025-06-10
09009607801301ViVi Helmet HPL80130801302023-11-10
09009607812000ViVi Hood80200V80200V2023-11-10

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
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
50885380019812CARDINAL 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