masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS

GUDID 00842289102125

TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches + 10 Single pouches)

NXSTAGE MEDICAL, INC.

Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle
Primary Device ID00842289102125
NIH Device Record Key4e336602-d96d-4b1e-959c-4d5a4db00781
Commercial Distribution StatusIn Commercial Distribution
Brand Namemasterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS
Version Model NumberD9-2005MGP
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

Device Dimensions

Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 Inch
Needle Gauge15 Gauge
Length1 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
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]
GS100842289102125 [Primary]

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 [masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS]

00842289102125TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS Total Case Qty 250 (120 Twin pouches
00842289102118TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGP

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