Identity
- Trade Name
- Atmos FDA UDI
- Generic Name
- Urodynamic manometric catheter, non-electronic FDA UDI
- Device Name
- For Bladder Pressure FDA UDI
- Model / Reference
- Single Sensor Bladder Air-Charged Urodynamics Catheter FDA UDI
- Description
- For Bladder Pressure FDA UDI
Identifiers
- Catalog Number
- 1B-AC FDA UDI
- Primary DI / UDI-DI
- 00850030696021 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Urodynamic manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Urodynamic manometric catheter, non-electronic
Atmos by Gemini Medical Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urodynamic manometric catheter, non-electronic.
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- Catheter, Pves & Vinf, Dual Lumen, 10Fr — Laborie Medical Technologies Canada ULC · Class II
- Bladder filling Catheter — Laborie Medical Technologies Canada ULC · Class II
- 2-lumen Catheter — Laborie Medical Technologies Canada ULC · Class II
- 2-lumen Catheter for Cystometry 8 Fr. (400 mm) — Laborie Medical Technologies Canada ULC · Class II
- Dual Lumen Catheter 9F — Laborie Medical Technologies Canada ULC · Class II
- Triple Lumen Catheter 7F Male — Laborie Medical Technologies Canada ULC · Class II
- Catheter, Pves & Vinf, Dual Lumen, 8Fr — Laborie Medical Technologies Canada ULC · Class II
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
- Gemini Medical Technologies, Llc
Sources (1)
- FDA UDI 88293eb0-9ec7-4fae-8872-79ff6240a0d7 35 fields · synced May 30, 2026