FDA.report

EM

Primary DI
00026072025543
Brand
EM
Company
Allied Medical, LLC
Model
L720
Device description
HALFBACK EXTRACT VEST W/COLOR
Published
2024-10-11
Public version status
New
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
FMRDevice, Transfer, Patient, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00026072025543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072025543000260720255430260720255430026072025543

GMDN Terms

TermDefinition
Chest impact protectorA device designed to be worn over the front of the chest to provide a padded garment to protect the chest from damage caused by falls against objects which would cause bruising and/or damage to the ribs. It is typically made from soft padded materials in the form of a vest and is held in place with bands or straps over the shoulders and around the back. It is typically used by persons who have tendencies for falls (e.g., due to loss of control of their motor system) and are prone to chest injury. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119066872
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
false
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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00026072014363PC11-10-00862024-11-05
00026072014387PC11-13-00072024-11-05
00026072014752PC12-01-42002024-11-05

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