FDA.reportPublic FDA data

SecureSafe Safety Insulin Syringe

Primary DI
00616784890524
Brand
SecureSafe Safety Insulin Syringe
Company
Dynarex Corporation
Model
8905
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150758000
K191639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150758000
K191639000TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.2020-09-11MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784890524PrimaryGS10
00616784890517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784890524006167848905246167848905240616784890524
00616784890517006167848905176167848905170616784890517

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"10111-62026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
00840117346253Pill Crusher Pouches with Round Corners4210R2026-07-31
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 22881562026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"81672026-07-31
00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03