AccessGUDID - DEVICE: True Comfort Insulin Syringes 31G 1/2CC 5/16" (00860000526555)

GUDID

Device Identifier (DI) Information

Brand Name: True Comfort Insulin Syringes 31G 1/2CC 5/16"
Version or Model: INS0531-0516
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1881
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00860000526555
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: (1/2cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.

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?
35904	Metered-delivery hypodermic syringe	A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. 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 [?]
K230061	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
Special Storage Condition, Specify: Insulin Syringes are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 31 Gauge
Device Size Text, specify: 1/2cc
Length: 0.3125 Inch

Device Record Status

Public Device Record Key: c64ad3d9-a4a1-4ae0-b936-28b794e24f09
Public Version Date: October 16, 2024
Public Version Number: 1
DI Record Publish Date: October 08, 2024