AccessGUDID - DEVICE: Alaris, SmartSite (10885403239571)

GUDID

Device Identifier (DI) Information

Brand Name: Alaris, SmartSite
Version or Model: 22001E-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22001E-07
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403239571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: Bag Access Device Needle-Free Valve, Vented/Nonvented 61 cm (24 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?
64996	Luer-formatted bag access spike	A small, noninvasive, tubular connector with a Luer connection (either lock or slip) at one end, and a hollow spike (either blunt or sharp) at the other end, intended to connect an intravenous (IV) fluid or blood bag to a fluid line or syringe for administration to a patient; it may in addition be used to draw medication from a vial, however it is not a vial/bottle adaptor. It may include an additional administration port (i.e., Y-site device), a built-in air filter, retention clamp, or valve(s); it does not however include tubing (i.e., not a tubing set). 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Inch

Device Record Status

Public Device Record Key: 68bb1880-e6ef-44ec-9032-f551f79624e2
Public Version Date: September 15, 2023
Public Version Number: 5
DI Record Publish Date: September 22, 2016