CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory CJ01050-00

GUDID 00860010587317

CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory

Vapocoolshot, Inc

Biopsy syringe holder, reusable

• Primary Device ID: 00860010587317
• NIH Device Record Key: bdbd8b57-0453-40e9-ba13-b6bdf1c5c12f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
• Version Model Number: CJ01050-00
• Catalog Number: CJ01050-00
• Company DUNS: 032313444
• Company Name: Vapocoolshot, Inc
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010587317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201248

FDA Product Code

• MLY: Vapocoolant Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

Devices Manufactured by Vapocoolshot, Inc

• 00860010587317 - CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory: 2025-08-11CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
• 00860010587317 - CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory: 2025-08-11 CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
• 00860010587324 - CoolJect Targeted-Mist Topical Anesthetic: 2025-08-11 CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (4 Wt. Oz). 1 canister.
• 10860010587321 - CoolJect Targeted-Mist Topical Anesthetic: 2025-08-11 CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (4 Wt. Oz). 12 Canisters per box.
• 00860006961503 - Coolject Topical Anesthetic Canister: 2024-11-19 Coolject Topical Anesthetic Canister
• 00860006961510 - Coolject 1-3cc Syringe Holder Nozzle Accessory: 2024-11-19 Coolject 1-3cc Syringe Holder Nozzle Accessory
• 20860006961507 - Coolject Topical Anesthetic Canister: 2024-11-19 Coolject Topical Anesthetic Canister. 3 per box
• 00860006961534 - Coolject 1-3cc Syringe Holder Nozzle Accessory: 2024-11-19 Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box
• 00860006961541 - Coolject Standard Nozzle Accessory: 2024-11-19 Coolject Standard Nozzle Accessory