FDA.report

Keybo Technologies Ltd. CPR Face Shield

Primary DI
B812KB3000BD0
Brand
Keybo Technologies Ltd. CPR Face Shield
Company
Keybo Technologies Ltd
Model
KB3000BD
Catalog number
KB3000BD
Published
2020-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BYPMouthpiece, Breathing

Product Code Classifications

CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B812KB3000BD0PrimaryHIBCC0

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mouthpiece/coverA non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator; it may also include directions/positional markers printed on the cover intended to assist the administrator during CPR. The mouthpiece is designed to be used as a barrier during resuscitation (i.e., “mouth-to-mouthpiece”) as an alternative to conventional “mouth-to-mouth”. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
416 855 3199mboadway@keybomedical.com

Regulatory Flags

DUNS number
243337016
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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