Dialysis Priming Set

GUDID 10842289102610

NXSTAGE MEDICAL, INC.

Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use
Primary Device ID10842289102610
NIH Device Record Keyb7971279-633f-48e7-9032-13104d57efec
Commercial Distribution StatusIn Commercial Distribution
Brand NameDialysis Priming Set
Version Model NumberM4-9440
Company DUNS088013219
Company NameNXSTAGE MEDICAL, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289102613 [Primary]
GS110842289102610 [Package]
Contains: 00842289102613
Package: Shipping Box [200 Units]
In Commercial Distribution

FDA Product Code

KOCAccessories, Blood Circuit, Hemodialysis

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-14
Device Publish Date2020-10-06

Devices Manufactured by NXSTAGE MEDICAL, INC.

10842289103044 - NxStage PureFlow Solution2024-04-04
10842289103051 - NxStage PureFlow Solution2024-04-04
10842289103068 - NxStage PureFlow Solution2024-04-04
10842289103075 - NxStage PureFlow Solution2024-04-04
10842289103082 - NxStage PureFlow Solution2024-04-04
10842289103099 - NxStage PureFlow Solution2024-04-04
10842289103105 - NxStage PureFlow Solution2024-04-04
10842289103112 - NxStage PureFlow Solution2024-04-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.