stay•safe® organizer

GUDID 10840861102317

Fresenius Medical Care Holdings, Inc.

Peritoneal dialysis manifold, single-use
Primary Device ID10840861102317
NIH Device Record Keyc02e68df-7539-4995-9d59-848acc92f1e0
Commercial Distribution StatusIn Commercial Distribution
Brand Namestay•safe® organizer
Version Model Number030-10807
Company DUNS958291411
Company NameFresenius Medical Care Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-323-5188
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861102310 [Primary]
GS110840861102317 [Package]
Contains: 00840861102310
Package: Case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FKXSystem, Peritoneal, Automatic Delivery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-21
Device Publish Date2019-05-09

Devices Manufactured by Fresenius Medical Care Holdings, Inc.

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