FDA.report

HarmonyAIR

Primary DI
00724995190002
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
A-Series Mobile Light
Catalog number
LAH0055
Device description
The A-Series High Density Mobile Light is used with the HarmonyAIR A-Series Lighting System.
Published
2020-05-29
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

Contact Domains

Product Codes

CodeName
FSSLight, surgical, floor standing

Product Code Classifications

CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995190002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995190002007249951900027249951900020724995190002

GMDN Terms

TermDefinition
Medical monitor/light standA mobile device designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. It is a mobile floor stand which may include wheels and/or articulated arms to enable dynamic positioning; the device to be supported (medical light/monitor) is not included.

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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00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13
00724995222086NATable ExtensionBF002662026-02-13
00724995222093NATable ExtensionBF002672026-02-13
00724995222109NATable ExtensionBF002682026-02-13
00724995244972NATAB800KTLBF7942026-02-13
00724995246891NATable Pad S00XWBF7682026-02-13
00724995246907NATable Pad S20CV3BF7692026-02-13

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M678NN90100NICOSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
20686864056816Medicom SafeMaskAMD Medicom IncFSS2025-01-23
03700712412029Maquet RoliteMAQUET SASFSS2024-11-07
04250613849282DM MS Sim.LED ExL DES.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849305MS Sim.LED OpL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
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04250613849367MS Sim.LED OpL USS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849404DM MS Sim.LED ExL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
03700712432508Maquet RoliteMAQUET SASFSS2024-06-20
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03700712432515Maquet RoliteMAQUET SASFSS2024-02-02
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03700712432539Maquet RoliteMAQUET SASFSS2023-12-15
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03700712422769Maquet RoliteMAQUET SASFSS2023-09-19
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03700712422851Maquet RoliteMAQUET SASFSS2023-09-19
00887761968554Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSS2023-07-11
03700712422707Maquet RoliteMAQUET SASFSS2023-05-26