FDA.reportPublic FDA data

Safe-Lock®

Primary DI
10840861100658
Brand
Safe-Lock®
Company
Fresenius Medical Care Holdings, Inc.
Model
050-30024
Device description
Safe-Lock® Catheter Adapter Sealing Cap
Published
2015-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKXSYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKXSystem, Peritoneal, Automatic DeliveryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822546000SAFE LOCK SEALING CAPSAmerican Medical Products, Inc.1982-10-13FKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100658PackageGS1150In Commercial Distribution
00840861100651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110065810840861100658
00840861100651008408611006518408611006510840861100651

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-5188xxx@xxx.xxx

Regulatory Flags#

DUNS number
958291411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04039361273590multiFluxF000131232026-09-29
04039361273613multiFluxF000131242026-09-29
00840861100774stay.safe®050-950032015-10-02
00840861101955NaturaLyte08-4112-208-4112-22015-10-02
10840861100542Fresenius04-9500-204-9500-22015-09-30
20840861100549Fresenius04-9500-204-9500-22015-09-30
008408611020822008T BlueStar Hemodialysis Machine1911242018-05-23
008408611020992008T BlueStar Hemodialysis Machine1911262018-05-23
008408611021052008T BlueStar Hemodialysis Machine1911282018-05-23
008408611021122008T BlueStar Hemodialysis Machine1911302018-05-23
00840861101122Crit-Line®CL100510012016-11-17
00840861101139Crit-Line®CL100410012016-11-17
00840861102068Liberty® Select Cycler1803432018-02-26
00840861102631FX CorAL 60 DialyzerF000092162024-02-23
00840861102655FX CorAL 100 DialyzerF000092182024-02-23
00840861102662FX CorAL 120 DialyzerF000092192024-02-23
00840861102679FX CorAL 600 DialyzerF000092202024-02-23
00840861102686FX CorAL 800 DialyzerF000092212024-02-23
00840861102693FX CorAL 1000 DialyzerF000092222024-02-23
10840861102638FX CorAL 60 DialyzerF000092162024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208288INTERGRATED APD SETVantive US Healthcare LLCFKX2026-10-21
07332414208301AUTOMATED PD SETVantive US Healthcare LLCFKX2026-10-21
07332414208509LOW RECIRCULATION VOLUME APD SETVantive US Healthcare LLCFKX2026-10-21
57332414206296Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemVantive Health GmbHFKX2026-09-22
57332414206319Sharesource Connectivity Platform for Use with the Amia APD SystemVantive US Healthcare LLCFKX2026-09-22
07332414202491Homechoice Claria APD CyclerVantive Health GmbHFKX2026-08-27
07332414208479HOMECHOICE APD SETVantive US Healthcare LLCFKX2025-10-16
08964004471001X-1 APD CyclerBYONYKS PRIVATE LIMITEDFKX2025-09-08
00085412030531NABaxter Healthcare SAFKX2025-08-28
50085412030536NABaxter Healthcare SAFKX2025-08-28
00840861102709LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102716LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102706LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102713LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102280VersiPDFresenius Usa, Inc.FKX2023-08-01
00840861102211VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102228VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102235VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102617VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102198VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102218VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102225VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102232VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102297VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102614VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00860006810238CloudCath Connect - Patient Monitoring SoftwareGastroklenz Inc.FKX2022-08-17
00860006810245CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810207CloudCath Drain Set - Baxter ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810269CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810283CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05