AccessGUDID - DEVICE: Model EMV+ Vent, Army, MRI (00847946020644)

GUDID

Device Identifier (DI) Information

Brand Name: Model EMV+ Vent, Army, MRI
Version or Model: 799-EMVP-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946020644
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: Ventilator

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
36289	Transport electric ventilator	An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
CBK	VENTILATOR, CONTINUOUS, FACILITY USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111473	000

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 Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Temperature: exactly 0 Degrees Celsius
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cfbb3560-cd09-4f70-b78d-66a36cda2bc7
Public Version Date: September 17, 2020
Public Version Number: 4
DI Record Publish Date: October 28, 2015