FDA.reportPublic FDA data

FareTec Compression Bandage

Primary DI
B5412221096B0
Brand
FareTec Compression Bandage
Company
FARETEC, INC.
Model
"Compression Bandage 6"""
Catalog number
2221096B
Device description
"6"" Compression Bandage, 6"" x 5 yards (15cm x 450cm). Consolidates the following: Pressure applicator, non-adherent pad, elastic secondary dressing, closure bar. "
Published
2020-08-31
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
B5412221096B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
First aid gauze/bandageA wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4403509510colleen@faretec.com

Regulatory Flags#

DUNS number
626802540
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B54133311390IFAKIFAK 5033311392025-04-18
B54133311380IFAKIFAK 4933311382025-03-28
B54133311370IFAKIFAK 4833311372025-03-14
B54133310470IFAKCombat Casualty IFAK (DLIFAK)33310472025-02-26
B54133311360IFAKIFAK 4733311362025-01-31
B54170019070IFAKTactical Medical Kit, Backpack70019072025-01-31
B54170019080IFAKTactical Medical Bag-Component70019082025-01-31
B54133311350IFAKIFAK 4633311352024-12-11
B54133311340IFAKUN IFAK Advanced Lot 3 Plus33311342024-12-04
B54133311320IFAKIFAK Kit Advanced33311322024-06-14
B54133311310IFAKIFAK 4433311312024-06-10
B54133311300IFAKUN IFAK Advanced33311302024-05-09
B54180030080Pelvic BinderPelvic Binder, Coyote Brown80030082024-02-28
B54133311280IFAKIFAK 4333311282024-01-26
B54133311250IFAKIFAK 4033311252023-12-20
B54133311260IFAKIFAK 4133311262023-12-20
B54133311270IFAKIFAK 4233311272023-12-20

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