AccessGUDID - DEVICE: HEPRO.US - Syringe with needle 1ml/cc 28G x1/2" (00850578007327)

GUDID

Device Identifier (DI) Information

Brand Name: HEPRO.US - Syringe with needle 1ml/cc 28G x1/2"
Version or Model: CT - 1ml/cc 28G x1/2"
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEPRO.US INC.

Primary DI Number: 00850578007327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2000
Labeler D-U-N-S® Number*: 080061451 *Terms of Use

Device Description: Hepro.us - Syringe with attached needle 1ml/cc 28G x1/2" - 100 pcs per box, 20 Box per Carton

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 960246b1-10a4-427e-b7a5-133dc7aa3bca
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 21, 2017