EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4" 37859S

GUDID 10020221078593

EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4"; 20PCS/BOX, 160PCS/CASE

Exel International

Subcutaneous infusion/injection port needle
Primary Device ID10020221078593
NIH Device Record Key9eb2796d-a380-404e-bd23-ce8b61b1b1b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4"
Version Model Number37859S
Catalog Number37859S
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
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
GS100020221078596 [Primary]
GS110020221078593 [Package]
Contains: 00020221078596
Package: Inner box [20 Units]
In Commercial Distribution
GS120020221078590 [Package]
Package: Case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-04-18
Device Publish Date2023-04-10

Devices Manufactured by Exel International

10020221260233 - EXEL 1/2mL INS SYR 28GX1/2"2024-12-03 EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN
20020221260032 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 29G x 1/2
20020221260049 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 31G x 1/4
20020221260056 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 31G x 1/3
20020221260063 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 31G x 1/6
10020221277644 - Exel SecureTouch Safety Blood Collection Set2024-03-19 Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
00020221277661 - Exel SecureTouch Safety Blood Collection Set2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 23G X 3/4, 12" tube
00020221277685 - Exel SecureTouch Safety Blood Collection Set2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.