AccessGUDID - DEVICE: EXEL ABS M-S L- ADAPTER (00020221765366)

GUDID

Device Identifier (DI) Information

Brand Name: EXEL ABS M-S L- ADAPTER
Version or Model: 26536BS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 26536BS
Company Name: Exel International

Primary DI Number: 00020221765366
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 180572216 *Terms of Use

Device Description: EXEL ABS M-S L- ADAPTER 1,000PCS/BAG, 5,000/CRTN #777036415

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?
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. 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 [?]
K861152	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: f59a0da0-5b92-40af-ae23-eb070297a1ea
Public Version Date: June 26, 2024
Public Version Number: 3
DI Record Publish Date: April 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10020221765363	1000	00020221765366	2024-03-01	Not in Commercial Distribution	Bag
20020221765360	5	10020221765363	2024-03-01	Not in Commercial Distribution	Shipping carton