Identity
- Trade Name
- Nasal Cannula FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Medium FDA UDI
- Model / Reference
- 8002 FDA UDI
- Description
- Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850068303021 FDA UDI
- 510(k) Number
- K233415 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal oxygen cannula, basic
Nasal Cannula by Remsleep Holdings Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, basic.
- NASAL CANNULA ADULT, WITH 14FT TUBE — BESMED HEALTH BUSINESS CORP. · Class I
- MedSource Nasal Cannula — MEDSOURCE INTERNATIONAL LLC · Class I
- Ventlab — Ventlab Corp. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- BF — Allied Medical LLC · Class I
Cleared under the same submission
K233415 also covers:
- Angled Adaptor — REMSLEEP HOLDINGS INC
- DeltaWave — REMSLEEP HOLDINGS INC
- DeltaWave Nasal Pillow System — REMSLEEP HOLDINGS INC
- Head strap — REMSLEEP HOLDINGS INC
- Hose assembly — REMSLEEP HOLDINGS INC
- Nasal Cannula — REMSLEEP HOLDINGS INC
- Nasal Cannula — REMSLEEP HOLDINGS INC
- Swivel Adaptor — REMSLEEP HOLDINGS 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 II | Pending data |
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Manufacturer
- Manufacturer
- Remsleep Holdings Inc
Sources (1)
- FDA UDI 390bd806-1e2c-4f21-a291-a65f3d48abda 34 fields · synced May 30, 2026