FDA.report

Bleeding Control Kit

Primary DI
B54133320000
Brand
Bleeding Control Kit
Company
FARETEC, INC.
Model
Bleeding Control Kit
Catalog number
3332000
Device description
Bleeding Control Kit, custom
Published
2020-08-31
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
OHOFirst Aid Kit Without Drug

Product Code Classifications

CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B54133320000PrimaryHIBCC0

GMDN Terms

TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
4403509510colleen@faretec.com

Regulatory Flags

DUNS number
626802540
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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