FDA.reportPublic FDA data

Halyard

Primary DI
20809160471712
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
MHLD95-01
Catalog number
MHLD95-01
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
20809160471712PackageGS110In Commercial Distribution
10809160471715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916047171220809160471712
1080916047171510809160471715

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
10809160521700HalyardDULP98-02_0001DULP98-022026-05-21
10809160521717HalyardLHMB9513-01_0004LHMB9513-012026-05-21
10809160521724HalyardNIHB0021-13_0003NIHB0021-132026-05-21
10809160521649HalyardNIHB0009-11_0007NIHB0009-112026-05-20
10809160521656HalyardNIHB0021-13_0011NIHB0021-132026-05-20
10809160521663HalyardNIHB0026-10_0003NIHB0026-102026-05-20
10809160521670HalyardNIHB0036-08_0006NIHB0036-082026-05-20
10809160521687HalyardNIHB0024-08_0006NIHB0024-082026-05-20
10809160521694HalyardWINN121-11_0002WINN121-112026-05-20
10809160521618HalyardSLCL55-02_0002SLCL55-022026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489215052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489215649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489410006Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489412673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489414646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489415773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489417289Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489418187Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419290Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419429Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489423730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489424089Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426229Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426410Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489430202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489443288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489446159Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489447286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454666Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489455946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489456899Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489459319Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10080196849710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24
10193489420562Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24
10193489426274Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-08-04
10193489431551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-16
10193489451238Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02
10193489457896Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02