EXEL HIS ROTATING WING, NON-DEHP W/Y 19GX3/4" 27941R

GUDID 10020221079415

EXEL HIS ROTATING WING, NON-DEHP W/Y 19GX3/4", 25/INNERBX, 50/BX, 20BX/CRTN

Exel International

Subcutaneous infusion/injection port needle
Primary Device ID10020221079415
NIH Device Record Keyd6bf2b28-11d4-4eb6-8960-e4fae13d4f04
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL HIS ROTATING WING, NON-DEHP W/Y 19GX3/4"
Version Model Number27941R
Catalog Number27941R
Company DUNS180572216
Company NameExel International
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100020221079418 [Primary]
GS110020221079415 [Package]
Contains: 00020221079418
Package: Box [25 Units]
In Commercial Distribution
GS120020221079412 [Package]
Package: Case [2 Units]
In Commercial Distribution
GS130020221079419 [Package]
Contains: 20020221079412
Package: Shipping carton [20 Units]
In Commercial Distribution

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-17
Device Publish Date2023-04-07

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