EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL 26280BNP

GUDID 10020221062806

EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL; 500/BAG, 1000/CRTN

Exel International

General-purpose syringe, single-use

Primary Device ID	10020221062806
NIH Device Record Key	fc960ff2-ad75-4f74-b93b-5e1eaaf6b795
Commercial Distribution Status	In Commercial Distribution
Brand Name	EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL
Version Model Number	26280BNP
Catalog Number	26280BNP
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	00020221062809 [Primary]
GS1	10020221062806 [Package] Contains: 00020221062809 Package: BAG [500 Units] In Commercial Distribution
GS1	20020221062803 [Package] Package: Shipping carton [2 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

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

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 [EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL]

10020221062806	EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL; 500/BAG, 1000/CRTN
00020221062809	EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL; 500/BAG, 1000/CRTN