FDA.report

ALLEN

Primary DI
00615521015503
Brand
ALLEN
Company
ALLEN MEDICAL SYSTEMS, INC.
Model
112003
Catalog number
GE5404080
Device description
Rail Extender, RH, US GE Part Number: 5404080 009
Published
2023-05-31
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
false

Related Records

Contact Domains

Product Codes

CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615521015503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521015503006155210155036155210155030615521015503

GMDN Terms

TermDefinition
Temporary cardiac pacing balloon catheterA sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags

DUNS number
147805894
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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00615521004408ArthrexAR-1627-11EU2024-05-23
00615521004415ArthrexAR-1627-11UK2024-05-23
00615521004422ArthrexAR-1627-122024-05-23
00615521004439ArthrexAR-1627-12EU2024-05-23
00615521004460ArthrexAR-1627-152024-05-23
00615521004491ArthrexAR-1627-172024-05-23
00615521004507ArthrexAR-1627-182024-05-23
00615521004514ArthrexAR-1627-202024-05-23
00615521004521ArthrexAR-1650-012024-05-23
00615521004552ArthrexAR-1650-042024-05-23
00615521004569ArthrexAR-1650-052024-05-23
00615521004583ArthrexAR-1650-072024-05-23
00615521004590ArthrexAR-1650-082024-05-23
00615521004606ArthrexAR-1650-092024-05-23
00615521004613ArthrexAR-1650-102024-05-23
00615521004620ArthrexAR-1650-112024-05-23
00615521004668ArthrexAR-1713-012024-05-23

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