AccessGUDID - DEVICE: Amico Patient Care Corporation (07540200000477)

GUDID

Device Identifier (DI) Information

Brand Name: Amico Patient Care Corporation
Version or Model: FMO-25-D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Amico Patient Care Corporation

Primary DI Number: 07540200000477
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259676661 *Terms of Use

Device Description: Dial Flowmeter, Oxygen, 25 LPM

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?
61366	Medical gas flowmeter, dial-type	A device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge

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: 09598451-2538-4d19-a22b-be32a75d44bc
Public Version Date: November 22, 2023
Public Version Number: 1
DI Record Publish Date: November 14, 2023