CODMAN BACTISEAL 821750

GUDID 10886704040996

CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set Includes: 35cm BACTISEAL Ventricular Catheter, Stylet, Connector, Cap, Catheter Anchoring Clip, Trocar and Information Manual

CODMAN & SHURTLEFF, INC.

Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term
Primary Device ID10886704040996
NIH Device Record Key1a64f3b3-d866-4776-9fbe-4628048a3148
Commercial Distribution StatusIn Commercial Distribution
Brand NameCODMAN BACTISEAL
Version Model Number82-1750
Catalog Number821750
Company DUNS607846297
Company NameCODMAN & SHURTLEFF, 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 Producttrue
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

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110886704040996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-22
Device Publish Date2015-09-20

On-Brand Devices [CODMAN BACTISEAL]

10886704046950CODMAN BACTISEAL Catheters Includes: BACTISEAL Barium Ventricular Catheter 15cm, Stylet, BACTISE
10886704046943CODMAN BACTISEAL Catheter Includes: BACTISEAL Barium Peritoneal Catheter 120cm and Information M
10886704045175CODMAN BACTISEAL Clear with Barium Stripe Catheter Kit Includes: BACTISEAL Clear with Barium Str
10886704045168CODMAN BACTISEAL Clear with Barium Stripe Distal Catheter, 120cm Includes: Information Manual
10886704041337CODMAN BACTISEAL Distal Catheter Kit with BACTISEAL Shunt System Contents: Distal Catheter 120cm
10886704041313CODMAN BACTISEAL Ventricular Catheter and Distal Catheter Kit with BACTISEAL Shunt System Conten
10886704047049CODMAN BACTISEAL EVD Catheter Set Includes: 35cm BACTISEAL Ventricular Catheter, 1mm Stylet, Con
10886704045205CODMAN BACTISEAL EVD 20cm Ventricular Catheter Set Includes: BACTISEAL EVD 20cm Catheter with St
10886704040996CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set Includes: 35cm BACTISEAL Ventricular
10886704040989CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set Includes 35cm Ventricular Catheter, Stylet, Connect
10886704040972CODMAN BACTISEAL EVD Catheter Set Includes 35cm Ventricular Catheter, Stylet, Connector, Cap, Ca

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