FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BMU 40
DI: 04037691349282
·
Model: BMU 40 Sensor 3/8"
·
Maquet Cardiopulmonary AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BMU 40
- Primary DI
- 04037691349282
- Version / Model
- BMU 40 Sensor 3/8"
- Catalog Number
- 70104.0849
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-18
- Public Version
- 4
- Public Version Date
- 2024-09-30
- Public Version Status
- Update
- Public Device Record Key
- 9f26f9a6-3976-4d59-9566-cbade089c938
- Distribution End Date
- 2024-09-25
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRY | MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31715 | Cardiopulmonary bypass system blood gas sensor | A sterile transducer used with a cardiopulmonary bypass system to detect and measure the partial pressure of gases in the blood being circulated by the system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04037691349220 | GS1 | 10 | Not in Commercial Distribution | 2024-09-25 | |
| Primary | 04037691349282 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090147 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 102.2 | Millimeter | |
| Outer Diameter | 0.375 | Inch |