FDA.report

HarmonyAIR

Primary DI
00724995165017
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
Utility Hub - LMC5212
Catalog number
LMC5212
Device description
The HarmonyAIR Utility Hub All Power Data Gas 47.25-inch Arm is a customizable unit for routing electricity, video and data, and a limited number of medical gasses to the operative site while reducing the number of wall plates needed and the routing of cords and wires on the floor.
Published
2021-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995165017PrimaryGS10

GMDN Terms

TermDefinition
General utility supply system, ceiling-mountedAn assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
036985604
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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