PICC WAND 91012

GUDID 30859821006156

The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

ACCESS SCIENTIFIC, LLC

Vascular catheter introduction set, nonimplantable
Primary Device ID30859821006156
NIH Device Record Key4e8a7088-c664-48bf-bb39-8042412b3775
Commercial Distribution StatusIn Commercial Distribution
Brand NamePICC WAND
Version Model Number6Fr
Catalog Number91012
Company DUNS079290879
Company NameACCESS SCIENTIFIC, LLC
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

Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French
Length7 Centimeter
Catheter Gauge6 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110859821006152 [Primary]
GS120859821006159 [Package]
Contains: 10859821006152
Package: Carton [10 Units]
In Commercial Distribution
GS130859821006156 [Package]
Contains: 20859821006159
Package: Overpack [18 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-09

On-Brand Devices [PICC WAND]

20859821006418PICC WAND Max Barrier Kit 6Fr
20859821006401PICC WAND Max Barrier Kit 5Fr
20859821006395PICC WAND Max Barrier Kit 4Fr
30859821006156The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
30859821006149The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
30859821006132The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

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