FDA UDI
In Commercial Distribution
🇺🇸 United States
Low-pressurehose assembly, 2m, 02 green DISS/ PURITAN BENNET
DI: 04054685271602
·
Model: 36334
·
WEINMANN Emergency Medical Technology GmbH + Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Low-pressurehose assembly, 2m, 02 green DISS/ PURITAN BENNET
- Primary DI
- 04054685271602
- Version / Model
- 36334
- 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
- 1
- Public Version Date
- 2020-12-15
- Public Version Status
- New
- Public Device Record Key
- ae1204db-ff69-4131-bb09-2d0bc3cd8357
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
- 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
- No
- 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 |
|---|---|---|---|---|
| 63209 | General-gas low pressure tubing, reusable | A non-sterile length of flexible tube intended to conduct compressed medical gas typically from a cylinder to a respiratory medical device outside of a static clinical environment (e.g., emergency CPAP device); it is not dedicated for use with a specific gas. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 15 bar), having been reduced by a regulator from a high pressure. The tubing is available in various lengths, including standard coil lengths; it is not colour-coded. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04054685271602 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193191 | 000 |