AccessGUDID - DEVICE: Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING (B2086345630)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING
Version or Model: 634563
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBAL DIABETIC DISTRIBUTORS INC

Primary DI Number: B2086345630
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796779283 *Terms of Use

Device Description: Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38501	Insulin syringe/needle, basic	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110421	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9673cd7-7dee-4a39-8adc-873c08ecf012
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B2086345633	6	B2086345632	In Commercial Distribution	Shipping Case
B2086345632	5	B2086345631	In Commercial Distribution	Inner Case
B2086345631	100	B2086345630	In Commercial Distribution	100