AccessGUDID - DEVICE: EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX (00020221064483)

GUDID

Device Identifier (DI) Information

Brand Name: EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX
Version or Model: 26448B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 26448B
Company Name: Exel International

Primary DI Number: 00020221064483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 180572216 *Terms of Use

Device Description: EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX Artwork referance numbers Per SP3106-10 DW0004108-02 - New Revision DW0004095-01 AW00068-02 - New Revision AW00069-03 - New Revision

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):	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?
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
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K861153	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64c8ad39-124a-4882-81aa-2c6d88a7eb86
Public Version Date: April 14, 2023
Public Version Number: 1
DI Record Publish Date: April 06, 2023