FDA.reportPublic FDA data

Freestyle Flex Tubing

Primary DI
07612367071734
Brand
Freestyle Flex Tubing
Company
Medela AG
Model
101038234
Published
2019-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191653000Freestyle FlexMedela AG2019-10-17HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612367071383PackageGS16In Commercial Distribution
07612367071734PackageGS1126In Commercial Distribution
07612367071376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612367071383076123670713837612367071383
07612367071734076123670717347612367071734
07612367071376076123670713767612367071376

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-435-8316customer.service@medela.com

Regulatory Flags#

DUNS number
488293218
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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
10080196144310MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10884389123997MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
14026704937360PLEUR-EVACTELEFLEX INCORPORATEDGAZ2026-05-08
16931918141206AllesetGRI Medical & Electronic Technology Co., Ltd.GAZ2025-06-20
10080196035106MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035120MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035151MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035168MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035243MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035250MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
14026704933119PLEUR-EVACTELEFLEX INCORPORATEDGAZ2024-11-18
08809083944803EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944810EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944827EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944834EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944841EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944858EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944865EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944872EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944889EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944896EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944902EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944919EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944926EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
20192253051909ArgyleCardinal Health 200, LLCGAZ2024-08-20
20192253051893ArgyleCardinal Health 200, LLCGAZ2024-08-19