FDA.reportPublic FDA data

Mini Compression Bandage

Primary DI
M689HHMCB01010
Brand
Mini Compression Bandage
Company
Safeguard US Operating, LLC
Model
01
Catalog number
HHMCB01
Device description
"1ea - sterile compression bandage w/ 4"" x 6"" pad and 34"" elastic wrap"
Published
2022-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689HHMCB01010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery compression bandage, single-useA non-sterile stretchable piece of fabric material intended to provide pressure for haemostasis to a punctured site on a patient having undergone femoral artery catheterization. It can be used as an alternative to direct hand pressure. This device may be T-shaped and constructed to wrap tightly around the patient's hips/thigh typically with a pressure point device inserted beneath it to augment compression. It is typically used following coronary angiography/ventriculography and percutaneous transluminal coronary angioplasty (PTCA); it may be used on brachial and radial arteries or after venipuncture. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

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Primary DI, Brand, Company table
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