AccessGUDID - DEVICE: Alaris, Signature Edition, SmartSite (10885403275401)

GUDID

Device Identifier (DI) Information

Brand Name: Alaris, Signature Edition, SmartSite
Version or Model: C72110E
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C72110E
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403275401
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: Infusion Burette Set, Smallbore Tubing Segments Needle-Free Valve (Burette) 2 Needle-Free Valves Vented/Nonvented 363 cm (143 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?
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. 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: 143 Inch

Device Record Status

Public Device Record Key: 7440014d-2c89-447a-a9f5-c7ac081d77b8
Public Version Date: July 26, 2024
Public Version Number: 7
DI Record Publish Date: September 22, 2016