FDA.report

MEDI

Primary DI
00837654862018
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
RLYUN002
Device description
COMFORT SILVER ARM LINER
Published
2018-11-20
Public version status
New
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

Product Codes

CodeName
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications

CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00837654862018PrimaryGS10

GMDN Terms

TermDefinition
Compression bandaging kitA collection of various types of non-sterile bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags

DUNS number
960754430
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00636257211472MEDIKBST2FG42026-03-17

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