FDA.reportPublic FDA data

Vario rail holder

Primary DI
07612367008709
Brand
Vario rail holder
Company
Medela AG
Model
077.0825
Published
2024-12-13
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
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153663000Vario 8/18/ciMedela AG2016-05-18BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367008709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367008709076123670087097612367008709

GMDN Terms#

Term, Definition table
TermDefinition
Desk mountA non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-735-1626info-healthcare@medela.com

Regulatory Flags#

DUNS number
488293218
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612367041201Invia Liberty Y-Connector with quick connector087.00232016-10-03
07612367016940Invia Liberty Carrying Case087.00312024-10-11
07612367060509Invia Motion Carrying Case087.40032024-10-11
07612367004176Disposable bacteria filter077.05742016-10-03
07612367004190Disposable bacteria /odour filter077.05762016-10-03
07612367011341Disposable Overflow Protection / Bacteria filter 077.05772016-10-03
07612367011365Filter paper for autoclavable bacteria filter077.10142021-09-01
07612367014250Disposable overflow protection /bacteria/odour filter077.00922016-10-03
07612367064712Disposable Overflow Protection / Bacteria Odour Filter1010352852019-04-30
07612367064743Disposable Overlfow Protection / Virus Odour Filter1010352862019-04-30
07612367064774Disposable Overflow Protection / Virus Odour Filter1010352872019-04-30
07612367064835Disposable virus filter 1010352842019-04-30
07612367064866Disposable virus / odour filter1010352882019-04-30
07612367064897Diposable virus / odour Filter1010352892019-04-30
07612367080569Filter paper for autoclavable bacteria filter077.10142021-09-01
07612367010924Filter, particle, Medela connection077.05822024-05-31
07612367011617Disposable tube 200cm077.09632024-05-31
07612367005104Angle piece 077.10152016-10-03
07612367005111Angle piece077.10162016-10-03
07612367016131Vario 18 AC/DC026.51202023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
00860014577512GROWNSYOak Tech LLCBTA2025-08-26
00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170232BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170249BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170256BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31