Identity
- Trade Name
- Nebu-Life FDA UDI
- Generic Name
- Medicine chamber spacer, single-use FDA UDI
- Device Name
- Nebu-Life Hand Held Nebulizer 6cc Cup. The Jet Nebulizer Bottle Set is used to administer various aerosal treatments to adults and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. FDA UDI
- Model / Reference
- RTG-07100 FDA UDI
- Description
- Nebu-Life Hand Held Nebulizer 6cc Cup. The Jet Nebulizer Bottle Set is used to administer various aerosal treatments to adults and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. FDA UDI
Identifiers
- Catalog Number
- RTG-07100 FDA UDI
- Primary DI / UDI-DI
- 00853292007475 FDA UDI
- 510(k) Number
- K091272 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Medicine chamber spacer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
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: Medicine chamber spacer, single-use
Nebu-Life by Cutting Edge Hc Brands Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medicine chamber spacer, single-use.
- Metered Dose Elbow — MEDICOMP, INC. · Class I
- Metered Dose Straight Swivel — MEDICOMP, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Nebu-Life — CUTTING EDGE HC BRANDS LLC · Class II
- Nebu-Life — CUTTING EDGE HC BRANDS LLC · Class II
- Nebu-Life — CUTTING EDGE HC BRANDS LLC · Class II
- Nebu-Life — CUTTING EDGE HC BRANDS LLC · Class II
- Nebu-Life — CUTTING EDGE HC BRANDS LLC · Class II
Cleared under the same submission
K091272 also covers:
- JET NEBULIZER MASK , CHILD SET 20CC 7Ft OXYGEN TUBING (Universal connector one e — BESMED HEALTH BUSINESS CORP.
- JET NEBULIZER MASK(SWIVEL) , ADULT SET 7Ft OXYGEN TUBING, GOBAL:63-510A — BESMED HEALTH BUSINESS CORP.
- MINI JET NEBULIZER SET 6CC (Screw);OD:18mm W/7Ft OXYGEN TUBING — BESMED HEALTH BUSINESS CORP.
- MINI JET NEBULIZER SET 6CC/OD:18mm(W/O CORRUGATE TUBING) — BESMED HEALTH BUSINESS CORP.
- MINI JET NEBULIZER SET 8CC W/7Ft OXYGEN TUBING — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE DISPOSABLE 6CC; — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE DISPOSABLE 6CC; OD:18mm — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE DISPOSABLE 6CC; OD:22mm — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm, ONE PIECE (SET OF 5) — BESMED HEALTH BUSINESS CORP.
- NEBULIZER SET 20CC W/T-PIECE, MOUTH PIECE — BESMED HEALTH BUSINESS CORP.
- Nebu-Life — CUTTING EDGE HC BRANDS LLC
- Nebu-Life — CUTTING EDGE HC BRANDS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cutting Edge Hc Brands Llc
Sources (1)
- FDA UDI d3ab55d1-eb36-4534-9b0f-9310e40f0733 37 fields · synced May 30, 2026