FDA.reportPublic FDA data

Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"

Primary DI
B2086315633
Brand
Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"
Company
GLOBAL DIABETIC DISTRIBUTORS INC
Model
631563
Device description
Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110421000DISPOSABLE INSULIN SYRINGEWenzhou Wuzhou Import & Export Co., Ltd.2011-04-26FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2086315631PackageHIBCC100In Commercial Distribution
B2086315632PackageHIBCC5In Commercial Distribution
B2086315633PackageHIBCC6In Commercial Distribution
B2086315630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796779283
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2084818010Easy Glide Hypodermic Needle 18g x 1in4818012026-02-02
B2084823010Easy Glide Hypodermic Needle 23g x 1in4823012026-02-02
B2084825010Easy Glide Hypodermic Needle 25g x 1in48-25012026-02-02
B2084830150Easy Glide Hypodermic Needle 30g x 1/2in4830152026-02-02
B2084818011Easy Glide Hypodermic Needle 18g x 1in4818012026-02-02
B2084823011Easy Glide Hypodermic Needle 23g x 1in4823012026-02-02
B2084825011Easy Glide Hypodermic Needle 25g x 1in48-25012026-02-02
B2084830151Easy Glide Hypodermic Needle 30g x 1/2in4830152026-02-02
B2086710200Easy Glide 10cc Luer Lock Syringe 6710202018-06-26
B2086713500Easy Glide 1cc Luer Lock Syringe 6713502018-06-26
B2086720200Easy Glide 20cc Luer Lock Syringe 6720202018-06-26
B2086730300Easy Glide 3cc Luer Lock Syringe 6730302018-06-26
B2086733300Easy Glide 30cc Luer Lock Syringe 6733302019-04-29
B2086760600Easy Glide 60cc Cath Tip Syringe 6760602018-03-15
B2086766600Easy Glide 60cc Luer Lock Syringe 6766602018-06-26
B2086720203Easy Glide 20cc Luer Lock Syringe 6720202018-06-26
B2086733303Easy Glide 30cc Luer Lock Syringe 6733302019-04-29
B2086730303Easy Glide 3cc Luer Lock Syringe 6730302018-06-26
B2086710203Easy Glide 10cc Luer Lock Syringe 6710202018-06-26
B2086713503Easy Glide 1cc Luer Lock Syringe 6713502018-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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