FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160146610
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
ADVG036-04_0003
Catalog number
ADVG036-04
Published
2017-05-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961225000CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETBaxter Healthcare Corp1996-06-21FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160146610PackageGS125In Commercial Distribution
10809160146613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916014661020809160146610
1080916014661310809160146613

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153AVIDComplaints@Owens-Minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
false
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
10809160522455HalyardAVMD023-03_0004AVMD023-032026-06-03
10809160522462HalyardDHOR82-01_0005DHOR82-012026-06-03
10809160522486HalyardLIFE0234-03_0001LIFE0234-032026-06-03
10809160522493HalyardAVMD011-03_0004AVMD011-032026-06-03
10809160522509HalyardAXOGSUB3-11_0016AXOGSUB3-112026-06-03
10809160522523HalyardMCTJ74-01_0011MCTJ74-012026-06-03
10809160522530HalyardPSJH0015-01_0012PSJH0015-012026-06-03
10809160522332HalyardEURO055_0005EURO0552026-06-02
10809160522349HalyardUSAR052-17_0004USAR052-172026-06-02
10809160522356HalyardWILF002-23_0003WILF002-232026-06-02
10809160522363HalyardSGRB86-04_0009SGRB86-042026-06-02
10809160522370HalyardWINN109-05_0015WINN109-052026-06-02
10809160522387HalyardONEL028-03_0007ONEL028-032026-06-02
10809160522394HalyardNAMC414-09_0004NAMC414-092026-06-02
10809160522400HalyardKAFB005-21_0005KAFB005-212026-06-02
10809160522417HalyardSGSP11-03_0003SGSP11-032026-06-02
10809160522424HalyardMEHY02O_0009MEHY02O2026-06-02
10809160522431HalyardBMHT033-02_0010BMHT033-022026-06-02
10809160522448HalyardDGLP47-02_0008DGLP47-022026-06-02
10809160522165HalyardEURO011-09_0003EURO011-092026-06-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30