Cycler Drain Bag Set 026-20226A

GUDID 00840861102037

Fresenius Medical Care Holdings, Inc.

Extracorporeal circuit waste bag, sterile
Primary Device ID00840861102037
NIH Device Record Key47336087-4f6f-48ee-b110-2edef872ab2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCycler Drain Bag Set
Version Model Number026-20226A
Catalog Number026-20226A
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861102037 [Primary]
GS110840861102034 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDJSet, Administration, For Peritoneal Dialysis, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-19
Device Publish Date2019-06-11

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