FDA.reportPublic FDA data

Halyard

Primary DI
20809160321437
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
OSUM153-05_0005
Catalog number
OSUM153-05
Published
2020-12-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160321437PackageGS150In Commercial Distribution
10809160321430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916032143720809160321437
1080916032143010809160321430

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
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
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
04573316385353KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
14573316385367KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316385377KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316388538KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
00849296016865WelmedWELMED INC.GAZ2026-02-15
00849296016872WelmedWELMED INC.GAZ2026-02-15
00849296016889WelmedWELMED INC.GAZ2026-02-15
00849296016896WelmedWELMED INC.GAZ2026-02-15
00849296016902WelmedWELMED INC.GAZ2026-02-15
00849296016919WelmedWELMED INC.GAZ2026-02-15
00849296016926WelmedWELMED INC.GAZ2026-02-15
00849296016933WelmedWELMED INC.GAZ2026-02-15
00849296016940WelmedWELMED INC.GAZ2026-02-15
00849296016957WelmedWELMED INC.GAZ2026-02-15
00849296016964WelmedWELMED INC.GAZ2026-02-15
00849296016971WelmedWELMED INC.GAZ2026-02-15
00849296016988WelmedWELMED INC.GAZ2026-02-15
00849296016995WelmedWELMED INC.GAZ2026-02-15
00849296017008WelmedWELMED INC.GAZ2026-02-15
00849296017015WelmedWELMED INC.GAZ2026-02-15
00849296017022WelmedWELMED INC.GAZ2026-02-15
00849296017039WelmedWELMED INC.GAZ2026-02-15
50885380072350CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10885380172519CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172526CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172533CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172557CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172571CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172595CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
00810130455478Medco Manufacturing IncMedco Manufacturing LLCGAZ2025-09-11