FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable breathing circuit, 1.70m
DI: 04054685129996
·
Model: 28110
·
WEINMANN Emergency Medical Technology GmbH + Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable breathing circuit, 1.70m
- Primary DI
- 04054685129996
- Version / Model
- 28110
- Company Name
- WEINMANN Emergency Medical Technology GmbH + Co. KG
- Labeler DUNS
- 342832477
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-07
- Public Version
- 2
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- e88ee308-e036-4985-aacf-ef7da81952de
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04054685129996 | GS1 | ||||
| Package | 04054685075750 | GS1 | 10 | In Commercial Distribution | ||
| Package | 04054685075767 | GS1 | 25 | In Commercial Distribution | ||
| Package | 04054685075774 | GS1 | 50 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193191 | 000 |