AccessGUDID - DEVICE: Rescue Breather CPR Protective Barrier (07540195055070)

GUDID

Device Identifier (DI) Information

Brand Name: Rescue Breather CPR Protective Barrier
Version or Model: 01RB2020-Royal Blue-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01RB2020-RB
Company Name: O-Two Medical Technologies Inc

Primary DI Number: 07540195055070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206449154 *Terms of Use

Device Description: The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Royal Blue nylon keychain/belt pouch.

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?
11961	Face splash shield, single-use	A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYM	Device, Cpr Assist

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K940927	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1301ad5c-6512-4c50-87a5-e1da6c783541
Public Version Date: April 06, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016