SF-NIH SF460

GUDID 10887714024525

A simgle lumen catheter used for injection of radiopaque media and pressure measurements of cardiovascular vessels / chambers.

NUMED, INC.

Angiographic catheter, single-use
Primary Device ID10887714024525
NIH Device Record Key19225346-3cb3-41a4-bf29-d4ef39f9655b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSF-NIH
Version Model Number317
Catalog NumberSF460
Company DUNS114186877
Company NameNUMED, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110887714024525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


[10887714024525]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [SF-NIH]

10887714024525A simgle lumen catheter used for injection of radiopaque media and pressure measurements of card
10887714024518A single lumen catheter used for injection of radiopaque media and pressure measurements of card

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