FDA.report

AMD-RITMED

Primary DI
20686864028561
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
5400-W
Catalog number
5400-W
Device description
AMD-RITMED O.R. TOWEL
Published
2019-01-15
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
FRLFiber, Medical, Absorbent
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864028561PackageGS14In Commercial Distribution
10686864028564PrimaryGS10
00686864028567Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686402856120686864028561
1068686402856410686864028564
00686864028567006868640285676868640285670686864028567

GMDN Terms

TermDefinition
Dry medical towel/wipe, single-useA dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
256880576
Device count
100
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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