AccessGUDID - DEVICE: Alaris, SmartSite (07613203011914)

GUDID

Device Identifier (DI) Information

Brand Name: Alaris, SmartSite
Version or Model: 20041E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20041E
Company Name: BD Switzerland Sàrl

Primary DI Number: 07613203011914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: Extension Set, Smallbore Tubing, T-Connector with Needle-Free Valve, 15 cm (6 in)

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

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: Fragile, handle with care
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size = Priming Volume = 0.2 millilitre (mL)
Length: 6 Inch

Device Record Status

Public Device Record Key: f71c242d-f521-411b-9030-60d9a68ed3a8
Public Version Date: July 31, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016