FDA.reportPublic FDA data

Arm-IR

Primary DI
00618125167197
Brand
Arm-IR
Company
TIDI PRODUCTS, LLC
Model
ARMIR07
Device description
Arm-IR Positioning Aids - Arm 1in x 1in x 1in 1 per Each
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KXJTable, radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00618125167197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125167197006181251671976181251671970618125167197

GMDN Terms

TermDefinition
Armboard, reusableA device designed to stabilize a patient's arm during an intervention or procedure typically to maintain the patency of an intravenous (IV) needle or an intravascular catheter. It is typically an elongated, flat surface of expanded polystyrene, wood, or artificial fibre board that is covered with a durable plastic or coating that can be easily cleaned. It may have a metal attachment so that it can be affixed to, e.g., an operating/examination table, a blood donor couch, or a chair, or it may be placed on a flat surface (e.g., on top of an operating/examination table). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
063519193
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
true
Sterilization required before use
false

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