FDA.report

MEDLINE

Primary DI
20193489190684
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ARTAB2000
Catalog number
ARTAB2000
Device description
STERILE ARMBOARD BENDABLE
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489190684PackageGS120In Commercial Distribution
10193489190687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348919068420193489190684
1019348919068710193489190687

GMDN Terms

TermDefinition
Arm procedure positioner, single-useA device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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