AccessGUDID - DEVICE: Curaplex (00815277025348)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 30070
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00815277025348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex Bag Valve Mask (BVM), Adult, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs

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?
36086	Pulmonary resuscitator, manual, single-use	A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTM	Ventilator, emergency, manual (resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053466	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
Total Volume: 1500 Milliliter

Device Record Status

Public Device Record Key: 13a317d0-ca38-4972-bf35-924d75795d72
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 14, 2016