FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160074036
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
MHSH2002_0008
Published
2016-09-15
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
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884792000VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLESInfucare Products, Inc.1989-01-30FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160074036PackageGS110In Commercial Distribution
10809160074039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916007403620809160074036
1080916007403910809160074039

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). 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
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
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
10809160522172HalyardWILF024-22_0001WILF024-222026-06-01
10809160522189HalyardWILF011-24_0001WILF011-242026-06-01
10809160522196HalyardSGRB86-04_0006SGRB86-042026-06-01
10809160522202HalyardWILF004-22_0001WILF004-222026-06-01
10809160522219HalyardWILF027-21_0001WILF027-212026-06-01
10809160522233HalyardAVMD023-03_0001AVMD023-032026-06-01
10809160522240HalyardWILF002-23_0001WILF002-232026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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10840330704875ProCureTwin Med, LLCFMI2026-05-27
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08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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