AccessGUDID - DEVICE: BD® Alaris™ Syringe Module, Model 8110 (10885403516047)

GUDID

Device Identifier (DI) Information

Brand Name: BD® Alaris™ Syringe Module, Model 8110
Version or Model: 8110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8110BDADXEN123
Company Name: CAREFUSION 303, INC.

Primary DI Number: 10885403516047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 360624720 *Terms of Use

Device Description: BD Alaris™ Syringe Module, Model 8110 v12.3.0

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
13217	Bedside syringe pump	A mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, infusion

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 101 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c4c9dc2-e0b8-401e-8d2d-5f472098ad56
Public Version Date: August 12, 2025
Public Version Number: 4
DI Record Publish Date: September 12, 2023