Identity
- Trade Name
- Everlywell Saliva Collection Kit FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
- Model / Reference
- 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- G7323001 FDA UDI
- FDA Product Code
- NNK FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral/respiratory tract specimen container IVD, no additive/medium
Everlywell Saliva Collection Kit by Everly Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/respiratory tract specimen container IVD, no additive/medium.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Salimetrics — SALIMETRICS LLC. · Class I
- BD Sputum Collection System — BECTON DICKINSON AND COMPANY · Class I
- Argyle — Cardinalhealth · Class II
- Salimetrics — SALIMETRICS LLC. · Class I
- Argyle — Cardinal Health 200, LLC · Class II
- Argyle — Cardinalhealth · Class II
- Caplugs/Evergreen — Caplugs, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Everly Health, Inc.
Sources (1)
- FDA UDI 23803890-41b5-4525-a2c5-498fe7f79bc9 32 fields · synced Jun 8, 2026