FDA.reportPublic FDA data

Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT

Primary DI
B2086345633
Brand
Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT
Company
GLOBAL DIABETIC DISTRIBUTORS INC
Model
634563
Device description
Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING
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
B2086345631PackageHIBCC100In Commercial Distribution
B2086345632PackageHIBCC5In Commercial Distribution
B2086345633PackageHIBCC6In Commercial Distribution
B2086345630PrimaryHIBCC0

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
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00840216124424LiteTouchAsp Global, LLCFMF2026-11-02
00840216124448LiteTouchAsp Global, LLCFMF2026-11-02
00840216124462LiteTouchAsp Global, LLCFMF2026-11-02
00840216123779LiteTouchAsp Global, LLCFMF2026-10-30
00840216123809LiteTouchAsp Global, LLCFMF2026-10-30
00840216123960LiteTouchAsp Global, LLCFMF2026-10-30
00840216123984LiteTouchAsp Global, LLCFMF2026-10-30
00840216124004LiteTouchAsp Global, LLCFMF2026-10-30
00840216124028LiteTouchAsp Global, LLCFMF2026-10-30
00840216124301LiteTouchAsp Global, LLCFMF2026-10-30
00840216124363LiteTouchAsp Global, LLCFMF2026-10-30
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04
00850091070372CoreCareCorecare Products Inc.FMF2026-09-04