Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector

GUDID 10842289102634

NXSTAGE MEDICAL, INC.

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Primary Device ID10842289102634
NIH Device Record Key722eea5b-9694-4109-af30-f661ea7c1a01
Commercial Distribution StatusIn Commercial Distribution
Brand NameFresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector
Version Model Number4R2441
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 Latextrue
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

Device Dimensions

Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch
Needle Gauge17 Gauge
Length1.25 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS100842289102637 [Primary]
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution
GS110842289102634 [Package]
Contains: 00842289102637
Package: Shipping Box [250 Units]
In Commercial Distribution

FDA Product Code

FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula
FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector]

108422891026344R2441
008422891026204R2440

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