FDA.reportPublic FDA data

Halyard

Primary DI
20809160472214
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AHCS77-01
Catalog number
AHCS77-01
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160472214PackageGS15In Commercial Distribution
10809160472217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916047221420809160472214
1080916047221710809160472217

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956449114CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956453258CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956472501CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956476196CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956488663CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956488700CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
50198956420531CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956421040CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956417753CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956419818CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420760CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956427820CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956310092CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956393774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956407365CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956408805CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956413946CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956318609CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956401363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956414950CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956418774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956278064CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956313925CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408706CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408959CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411416CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411775CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956366099CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09