AccessGUDID - DEVICE: Alaris, SmartSite, Texium (10885403250781)

GUDID

Device Identifier (DI) Information

Brand Name: Alaris, SmartSite, Texium
Version or Model: 22005E-07T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22005E-07T
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403250781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: Extension Set, Microbore Tubing, Needle-Free Valve, Closed Male Luer Priming Cap (orange colored) 158 cm (62 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
LHI	Set, i.V. Fluid transfer

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
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 62 Inch

Device Record Status

Public Device Record Key: 6efc7b36-0921-4705-8361-f63875f17b21
Public Version Date: March 06, 2024
Public Version Number: 5
DI Record Publish Date: September 22, 2016