AccessGUDID - DEVICE: True-Comfort Pen Needles 4mm (00850058864105)

GUDID

Device Identifier (DI) Information

Brand Name: True-Comfort Pen Needles 4mm
Version or Model: I23204 or INSP32-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1775
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00850058864105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: 100ct box. 32G x 5/32 (4mm) Single use disposable pen needle for use with most insulin delivery systems. 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?
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Pens Needles 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
Length: 4 Micrometer
Needle Gauge: 32 Gauge

Device Record Status

Public Device Record Key: 8465b2ea-932f-4d7a-8b92-a0c7dfb78ea2
Public Version Date: July 05, 2024
Public Version Number: 1
DI Record Publish Date: June 27, 2024