Identity
- Trade Name
- Coolject Standard Nozzle Accessory FDA UDI
- Generic Name
- Cold/cool therapy spray FDA UDI
- Device Name
- Coolject Standard Nozzle Accessory, One per Box FDA UDI
- Model / Reference
- VM01100-00 FDA UDI
- Description
- Coolject Standard Nozzle Accessory, One per Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006961558 FDA UDI
- 510(k) Number
- K193349 FDA UDI
- FDA Product Code
- MLY FDA UDI
- GMDN Term
- Cold/cool therapy spray FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cold/cool therapy spray
Coolject Standard Nozzle Accessory by Vapocoolshot, Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193349 also covers:
- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc
- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc
- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc
- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc
- Coolject Standard Nozzle Accessory — Vapocoolshot, Inc
- Coolject Topical Anesthetic Canister — Vapocoolshot, Inc
- Coolject Topical Anesthetic Canister — Vapocoolshot, Inc
- Coolject Topical Anesthetic Canister — Vapocoolshot, Inc
- Coolject Topical Anesthetic Canister — Vapocoolshot, Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Vapocoolshot, Inc
Sources (1)
- FDA UDI eb64936a-6af8-4a16-940e-a5c274bf764c 34 fields · synced Jun 8, 2026