FDA.reportPublic FDA data

SAFIRA

Primary DI
05060727270013
Brand
SAFIRA
Company
MEDOVATE LIMITED
Model
SAFIRA Foot Pedal
Catalog number
900044
Device description
SAFIRA system foot operator for controlling SAFIRA Driver
Published
2020-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153599000
K230083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153599000Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC2016-09-01FRN
K230083000SAFIRAMedovate Limited2023-10-31FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060727270013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060727270013050607272700135060727270013

GMDN Terms#

Term, Definition table
TermDefinition
Pain management medication delivery systemAn assembly of devices intended to be used by a healthcare professional (e.g., orthopaedist, pain management specialist, rheumatologist) for the intermittent delivery of liquid medication in a controlled manner to manage pain in various applications [e. g, intra-articular, epidural site(s), and nerve blocks]. It typically consists of a mains electricity (AC-powered) multichannel delivery pump, a disposable cassette, vial transfer spikes, and a handpiece/tubing set. The system automates aspects of the injection procedure otherwise performed by manual syringe and typically records treatment information for patient records; it may interface with an external ultrasound (US) system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401223901991enquires@medovate.co.uk

Regulatory Flags#

DUNS number
223136416
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060844770014SAFIRASAFIRA Driver9000292026-10-05
05060844770021SAFIRASAFIRA Luer Syringe9000212026-10-05
05060844770038SAFIRASAFIRA NRFit Syringe9000582026-10-05
05060844770045SAFIRASAFIRA Palm Operator9000592026-10-05
05060844770052SAFIRASAFIRA Foot Pedal9000442026-10-05
05060727270037SAFIRASAFIRA Syringe 9000162020-04-20
05060727270051SAFIRASAFIRA NRFit Syringe9000582021-03-30
05060727270068SAFIRASAFIRA Palm Operator9000592021-12-10
05060727270020SAFIRASAFIRA Driver9000292020-04-20
35060727270052SAFIRASAFIRA NRFit Syringe9000582021-03-30
35060727270038SAFIRASAFIRA Syringe 9000162020-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29