AccessGUDID - DEVICE: Syringe, Calibration, Adj. Vol., Aluminum, A-M Systems (00817081026559)

GUDID

Device Identifier (DI) Information

Brand Name: Syringe, Calibration, Adj. Vol., Aluminum, A-M Systems
Version or Model: Syringe, Calibration, Adj. Vol., Aluminum, A-M Systems
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 192800
Company Name: A-M SYSTEMS, LLC

Primary DI Number: 00817081026559
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020275145 *Terms of Use

Device Description: Syringe, Calibration, Adjustable Volume, Aluminum, A-M Systems

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":	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?
17250	Spirometer/pulmonary function analyser syringe	A dedicated piston-in-barrel used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. It is typically a glass or plastic cylinder (barrel) and steel plunger (piston) with a finely graduated scale along the length of the cylinder. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXW	Calibrator, Volume, Gas

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 466b180c-87f6-4ed7-90e6-058862ee9e15
Public Version Date: April 20, 2020
Public Version Number: 1
DI Record Publish Date: April 11, 2020