3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 26201BB

GUDID 10020221162018

3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN

Exel International

General-purpose syringe, single-use

Primary Device ID	10020221162018
NIH Device Record Key	c97bbb88-9549-4e74-b07d-590066cfe65e
Commercial Distribution Status	In Commercial Distribution
Brand Name	3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL;
Version Model Number	26201BB
Catalog Number	26201BB
Company DUNS	180572216
Company Name	Exel International
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221162011 [Primary]
GS1	10020221162018 [Package] Contains: 00020221162011 Package: Bag [2000 Units] In Commercial Distribution
GS1	20020221162015 [Package] Package: Shipping carton [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K861153

FDA Product Code

FMF	Syringe, Piston

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

[10020221162018]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-13
Device Publish Date	2023-04-05

On-Brand Devices [3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL;]

10020221162018	3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN
00020221162011	3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN