FDA.reportPublic FDA data

Bleeding Control Basic Kit

Primary DI
M689BCBK010
Brand
Bleeding Control Basic Kit
Company
Safeguard US Operating, LLC
Model
1
Catalog number
BCBK
Device description
1 SWAT-T Tourniquet1 Mini 2X Gauze + Compression1 Pair Gloves, Blue, Industrial
Published
2022-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689BCBK010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

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