FDA.reportPublic FDA data

Halyard

Primary DI
20680651681908
Brand
Halyard
Company
O&M HALYARD, INC.
Model
68190
Catalog number
68190
Device description
HALYARD,H500,STRWRP,-,54X90,50
Published
2016-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651681905PackageGS12In Commercial Distribution
20680651681908PrimaryGS10
90680651681907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065168190530680651681905
2068065168190820680651681908
9068065168190790680651681907

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
081057389
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14
20680651509660Halyard50966509662026-05-14
20680651509677Halyard50967509672026-05-14
20680651509684Halyard50968509682026-05-14
20680651484219Halyard48421484212022-05-06
20680651484226Halyard48422484222022-05-06
10680651385250Halyard38525385252023-07-31
20680651372219Halyard37221372212020-11-16
20680651372509Halyard37250372502020-11-16
20680651718000Halyard71800718002020-08-31
20680651718253Halyard71825718252020-11-16
20680651719007Halyard71900719002020-11-16
30680651494390Halyard49439494392025-03-26
30680651494406Halyard49440494402025-03-26
30680651494413Halyard49441494412025-03-26
30680651494420Halyard49442494422025-03-26
30680651494437Halyard49443494432025-03-26
20680651395072Halyard39507395072020-09-15
20680651395089Halyard39508395082020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
08404535025927Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-01
08404535015003Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535019100Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025217Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025248Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025279Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
10197344140008MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140015MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140022MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149018MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149025MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149032MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10198459366277MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FRG2025-06-16
10197344695331MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695348MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695355MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695362MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695379MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10304040172046Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10304040172053Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10686864044786Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044793Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044809Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044816Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044823Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044830Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044847Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
H66810503101PrehmaKeystone IndustriesFRG2023-02-20
H66810504101PrehmaKeystone IndustriesFRG2023-02-20