FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682134880
·
Model: ABS ABSORBENT CANISTER REUSABLE
·
DATEX-OHMEDA INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00840682134880
- Version / Model
- ABS ABSORBENT CANISTER REUSABLE
- Company Name
- DATEX-OHMEDA INC
- Labeler DUNS
- 129501685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-18
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fc14a408-36bb-46bb-905d-fc0c2a406a16
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| BSF | ABSORBER, CARBON-DIOXIDE | Anesthesiology | 868.5310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37022 | Carbon dioxide absorber, reusable | A non-sterile, refillable container (e.g., a canister) intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime), directly or via a single-use absorbent cartridge, to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682134880 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 60 Degrees Celsius