FDA.report

AMD-RITMED

Primary DI
20686864051644
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
A632
Catalog number
A632
Device description
AMD-RITMED ELASTIC BANDAGE ROLL WITH VELCRO 2 Inch X 5 Yard
Published
2019-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864051644PackageGS15In Commercial Distribution
10686864051647PrimaryGS10
00686864051640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405164420686864051644
1068686405164710686864051647
00686864051640006868640516406868640516400686864051640

GMDN Terms

TermDefinition
Pressure bandage, non-latex, reusableA strip or roll of fabric or plastic material intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., treatment of lymphoedema, venous oedema and lipoedema, support injuries associated with minor trauma), and/or to secure hot/cold packs to the body to provide heat/cold therapy. It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(514)636-6262amdudi@medicom.ca

Regulatory Flags

DUNS number
256880576
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

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20686864051538AMD-RITMEDA60044A600442019-01-13
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20686864061384Medicom AssureTouch9940-B9940-B2025-04-24
00686864061397Medicom AssureTouch9940-C9940-C2025-04-24
20686864061407Medicom AssureTouch9940-D9940-D2025-04-24
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