FDA.reportPublic FDA data

AIR-FLOW-PIEZON

Primary DI
07613353185343
Brand
AIR-FLOW-PIEZON
Company
E.M.S. Electro Medical Systems S.A.
Model
DW-048B
Device description
AIRFLOW Station
Published
2021-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190124000EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A2019-10-20ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353185343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353185343076133531853437613353185343

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353313500GBT Machine StationDW-1002026-02-16
04262477320197SONOGELDV-1552025-09-02
04260153472031Swiss DolorClastDV-0332021-06-02
07613353170264Swiss DolorClastDV-0332020-06-03
07613353352356GBT Machine AIRFLOW Prophylaxis MasterFT-300#NFSFT-300 -01-202026-02-24
07613353180089Instruments A P PSFS-4582026-02-16
07613353180096Instruments PS PSR PSLFS-4592026-02-16
07613353225940GBT FLOWCONTROL x 4FV-112/A2026-02-16
07613353331184GBT Machine Wireless PedalEK-1055B2026-02-16
07613353334925AIR-FLOWFS-465FS-465/MX2026-02-16
07613353335847AIR-FLOWFS-477/US2026-02-16
07613353336837Instruments PSR PSLFS-4612026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2B 3022026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2BV022026-02-16
07613353348137AIR-FLOWFS-474FS-474/MX2026-02-16
07613353335113PIEZONFS-4552025-10-21
07613353341404PiezonEN-060#MX2025-10-21
07613353257224AIR-FLOW-PIEZONFT-229Default2025-10-20
07613353257323AIR-FLOW-PIEZONFT-229-2B-V022025-10-20
07613353257576AIR-FLOW-PIEZONFT-229-2B-3022025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479200774ALL SURFACE KITRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-04-03
00840479201191ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201207ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201214ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201245ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201252ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201269ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201276ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201283ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201290ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201306ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201313ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479202587ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
07613353225940GBT FLOWCONTROL x 4E.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353331184GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353334925AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353348137AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
07613353257866AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2025-10-20
07613353334932AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2025-07-07
06944843611587woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843611594DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843611600woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843611617DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843655987DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843616872LOVE HYGIENEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-08-09
10889950142551PWR PairHU-FRIEDY MFG. CO., LLCKOJ2024-07-17