FDA.reportPublic FDA data

AccuSert

Primary DI
00817708022964
Brand
AccuSert
Company
EMED TECHNOLOGIES CORPORATION
Model
FP-0010033
Device description
OPTFlow Needle Inserter
Published
2022-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213429000AccuSert Needle InserterEmed Technologies Corporation2022-10-20KZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817708022964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817708022964008177080229648177080229640817708022964

GMDN Terms#

Term, Definition table
TermDefinition
Injector reset deviceA device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622637544
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817708022957Tetra MicroTM-20FP-00102132026-02-24
00817708022971Tetra MicroFP-0010214FP-00102142026-02-24
00817708023374Tetra MicroFP-0010215FP-00102152026-02-24
00817708023428Tetra MicroFP-0010216FP-00102162026-02-24
00817708023435Tetra MicroTM-50FP-00102122026-02-24
00817708023411OPTFlowOPT12609-46Q10OPT12609-46Q102026-01-09
10817708023418OPTFlowOPT12609-46Q10OPT12609-46Q102026-01-09
00817708023381EMED Soluble Hemostatic GauzeEHEM22-10EHEM22-102019-01-30
00817708023398SCIg60FP-00100322020-08-07
00817708020274SCIg60 Infusion SystemFP-0010002FP-00100022016-09-23
10817708020554SAF-QSAF-Q-106-G24-Q10SAF-Q-106-G24-Q102020-12-07
10817708020578SAF-QSAF-Q-106-G27-Q10SAF-Q-106-G27-Q102020-12-07
10817708020615SAF-QSAF-Q-106-SNF-Q10SAF-Q-106-SNF-Q102020-12-07
10817708020639SAF-QSAF-Q-109-G24-Q10SAF-Q-109-G24-Q102020-12-07
10817708020677SAF-QSAF-Q-109-G27-Q10SAF-Q-109-G27-Q102020-12-07
10817708020691SAF-QSAF-Q-109-G27-SNF-Q10SAF-Q-109-G27-SNF-Q102020-12-07
10817708020714SAF-QSAF-Q-112-G24-70-Q10SAF-Q-112-G24-70-Q102020-12-07
10817708020738SAF-QSAF-Q-112-G27-Q10SAF-Q-112-G27-Q102020-12-07
10817708021155SUB-QSUB-104-G27-Q10SUB-104-G27-Q102020-12-07
10817708021179SUB-QSUB-106-G27-Q10SUB-106-G27-Q102020-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00817708022988AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
00763000573690MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
05713495000077Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
05713495000084Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
00763000381080Sil-serter™MEDTRONIC MINIMED, INC.KZH2021-04-22
00763000354817MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2020-06-14
05713495000015BETACONNECTPhillips-Medisize A/SKZH2019-10-07
00355513192019Onpro kitAMGEN INC.KZH2019-09-24
10355513192016Onpro kitAMGEN INC.KZH2019-09-24
00301697712901FlexPro® PenMate®NOVO NORDISK INC.KZH2019-08-08
00025294874007Inject-EaseAMBI, INC.KZH2018-12-17
57612799202398Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24
47612799202391Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24