ButtonHole with SteriPick NEEDLE SET

GUDID 10842289102504

NXSTAGE MEDICAL, INC.

Haemodialysis needle
Primary Device ID10842289102504
NIH Device Record Key7af493eb-e9a7-47cc-9cc0-7cb78337db21
Commercial Distribution StatusIn Commercial Distribution
Brand NameButtonHole with SteriPick NEEDLE SET
Version Model NumberBH-7005PE
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289102507 [Primary]
GS110842289102504 [Package]
Contains: 00842289102507
Package: Shipping Box [250 Units]
In Commercial Distribution

FDA Product Code

FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-07
Device Publish Date2020-06-29

On-Brand Devices [ButtonHole with SteriPick NEEDLE SET]

00842289102354SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2037
00842289102347SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2036
00842289102330SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2035
00842289102323SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" WITH STERIPICK INCLUDED WITH TWINPACK BH-2007
00842289102316SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" WITH STERIPICK INCLUDED WITH TWIN PACK BH-200
00842289102309SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" WITH STERIPICK INCLUDED WITH TWIN PACK BH-200
00842289102293SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 14G X 1" W/ STERIPICK INCLUDED WITH TWINPACK BH-2004PE
10842289102566BH-7606PE
10842289102559BH-7605PE
10842289102511BH-7006PE
10842289102504BH-7005PE
10842289102498BH-7004PE
10842289102481BH-4006PE
10842289102474BH-4005PE
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