FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Aerosol Drainage Bag
DI: 00840117311978
·
Model: 34200
·
DYNAREX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Resp-O2 Aerosol Drainage Bag
- Primary DI
- 00840117311978
- Version / Model
- 34200
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 2
- Public Version Date
- 2023-02-28
- Public Version Status
- Update
- Public Device Record Key
- a5102d56-97c5-4e69-a828-c1fe2ea6a176
Device Description
Resp-O2Aerosol Drainage Bag w/ Y-Adaptor; 750cc, Accepts Standard 22mm ID corrugated tubing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | Anesthesiology | 868.5995 | 1 |
| BTC | Bag, Reservoir | Anesthesiology | 868.5320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58337 | Thermal vapour lung treatment system drainage bag | A non-sterile plastic pouch intended to collect the effluent (water) from a thermal vapour lung treatment system generator after the water vapour has cooled and condensed. It typically has tabs for attachment to the generator trolley. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840117311985 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00840117311978 | GS1 |