FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160146613
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
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 typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160528365HalyardPSJH0015-02_0014PSJH0015-022026-08-03
10809160528372HalyardSFSAKOR36-02_0001SFSAKOR36-022026-08-03
10809160528389HalyardAKOR36-03_0002AKOR36-032026-08-03
10809160528396HalyardAKCR19-03_0003AKCR19-032026-08-03
10809160528402HalyardBMHT500-03_0005BMHT500-032026-08-03
10809160528419HalyardBMHU006-07_0007BMHU006-072026-08-03
10809160528426HalyardSELF137-05_0005SELF137-052026-08-03
10809160528433HalyardLANC039-31_0002LANC039-312026-08-03
10809160528440HalyardBMHT202-05_0004BMHT202-052026-08-03
10809160528457HalyardBMHT401-04_0006BMHT401-042026-08-03
10809160528464HalyardESCC82-02_0010ESCC82-022026-08-03
10809160528471HalyardLANC015-35_0011LANC015-352026-08-03
10809160528488HalyardBMHT400-03_0013BMHT400-032026-08-03
10809160528495HalyardBAMW001-03_0002BAMW001-032026-08-03
10809160528501HalyardQPTH29-02_0007QPTH29-022026-08-03
10809160528518HalyardSFSBMHU006-07_0001SFSBMHU006-072026-08-03
10809160528525HalyardHVBM219-04_0005HVBM219-042026-08-03
10809160528532HalyardSFSBAMW001-03_0001SFSBAMW001-032026-08-03
10809160528549HalyardMEEN42-03_0007MEEN42-032026-08-03
10809160528556HalyardDAMH300-03_0005DAMH300-032026-08-03

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