FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160065614
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
FIST017-01_0001
Published
2016-09-09
Public version status
Update
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
OGDCustom anesthesia tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160065614PackageGS112In Commercial Distribution
10809160065617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916006561420809160065614
1080916006561710809160065617

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological irrigation kit, single-useA collection of sterile devices designed to cleanse or flush a cavity or canal with sterile water or other fluid during a gastroenterological/urological (GU) procedure. It typically consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary/urinary tracts. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539392HALYARDGBCC47-02GBCC47-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538975HalyardAVID MEDICAL, INC.OGD2026-09-24
10809160538579HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-22
10809160536551HalyardAVID MEDICAL, INC.OGD2026-09-18
10809160536612HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
10809160536629HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
10809160536728HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
10809160536834HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
00858965006946NAPAJUNK MEDICAL SYSTEMS, LPOGD2026-08-07
10809160528426HalyardAVID MEDICAL, INC.OGD2026-08-03
10809160527863HalyardAVID MEDICAL, INC.OGD2026-07-28
10809160522936HalyardAVID MEDICAL, INC.OGD2026-06-08
10809160523018HalyardAVID MEDICAL, INC.OGD2026-06-08
10194717116219Regard™ROI CPS, LLCOGD2022-10-05
10194717115106Regard™ROI CPS, LLCOGD2022-03-22
10194717113881Regard™ROI CPS, LLCOGD2021-11-19
10195594417451CARDINAL HEALTHCardinal Health 200, LLCOGD2021-11-05
10193489361940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGD2021-08-27
10194717112761Regard™ROI CPS, LLCOGD2021-07-28
10194717110590Regard™ROI CPS, LLCOGD2021-05-10
10194717109730Regard™ROI CPS, LLCOGD2021-02-15
10194717109372Regard™ROI CPS, LLCOGD2021-01-14
10194717108924RegardROI CPS, LLCOGD2020-12-10
10194717107675Regard™ROI CPS, LLCOGD2020-06-25
10194717106982Regard™ROI CPS, LLCOGD2020-01-23
10194717101222Regard™ROI CPS, LLCOGD2019-12-23
10194717103042Regard™ROI CPS, LLCOGD2019-12-10
10194717102434Regard™ROI CPS, LLCOGD2019-11-01
10326053117340Regard™Resource Optimization & Innovation, L.L.C.OGD2019-09-18
10326053114363Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2018-03-28
10326053108713Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23