EXEL HYPO NDL 16GX1" BULK, NON-STERILE 26421BN

GUDID 10020221664215

EXEL HYPO NDL 16GX1" BULK, NON-STERILE

Exel International

Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use

Primary Device ID	10020221664215
NIH Device Record Key	584df49e-f1eb-4715-b3eb-702f3aea4721
Commercial Distribution Status	In Commercial Distribution
Brand Name	EXEL HYPO NDL 16GX1" BULK, NON-STERILE
Version Model Number	26421BN
Catalog Number	26421BN
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
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
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
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	00020221664218 [Primary]
GS1	10020221664215 [Package] Contains: 00020221664218 Package: Shipping carton [20000 Units] In Commercial Distribution
GS1	20020221664212 [Package] Package: Shipping carton [4 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K861153

FDA Product Code

FMF	Syringe, Piston

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-03
Device Publish Date	2023-03-24

Devices Manufactured by Exel International

10020221277644 - Exel SecureTouch Safety Blood Collection Set	2024-03-19 Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
00020221277661 - Exel SecureTouch Safety Blood Collection Set	2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 23G X 3/4, 12" tube
00020221277685 - Exel SecureTouch Safety Blood Collection Set	2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube
10020221017127 - Advance Plus Universal IV Administration Set	2023-11-08 IV Administration Set, Luer Lock/Slip, 12" tubing
00020221017205 - Advance Plus Universal IV Administration Set	2023-11-08 IV Administration Set, Luer Lock/Slip, 20" tubing
10020221017301 - Advance Plus Universal IV Administration Set	2023-11-08 IV Administration Set, Luer Lock/Slip, 30" tubing
10020221017721 - Advance Plus Universal IV Administration Set	2023-11-08 IV Administration Set, 72" tubing
10020221117209 - Advance Plus Universal IV Administration Set	2023-11-08 IV Administration Set, Luer Slip, 1 injection site, 20" tubing