EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 3/4" 37849S

GUDID 10020221078494

EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 3/4"; 20PCS/BOX, 8BX/CS

Exel International

Subcutaneous infusion/injection port needle
Primary Device ID10020221078494
NIH Device Record Keye7cca448-e3f2-41b7-aa07-e55211e301d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 3/4"
Version Model Number37849S
Catalog Number37849S
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
GS100020221078497 [Primary]
GS110020221078494 [Package]
Contains: 00020221078497
Package: Inner box [20 Units]
In Commercial Distribution
GS120020221078491 [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

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00020221162011 - 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL;2025-10-07 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN
00020221163001 - EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL2025-10-07 EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL ; 140/BOX, 560/CRTN
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00020221660487 - EXEL 1mL TB SYR ONLY,BULK,N-S 2025-10-07 EXEL 1mL TB SYR ONLY,BULK,N-S 2000/BAG, 4,000/CS
00020221660494 - EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE 2025-10-07 EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE 2000/BAG, 4000/CS

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