FDA UDI
In Commercial Distribution
🇺🇸 United States
NIBP Pressure cuff 27 - 35 cm
DI: EMIP51000410
·
Model: Adult 27 - 35 cm
·
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NIBP Pressure cuff 27 - 35 cm
- Primary DI
- EMIP51000410
- Version / Model
- Adult 27 - 35 cm
- Catalog Number
- 5100041
- Company Name
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Labeler DUNS
- 324416379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-11
- Public Version
- 1
- Public Version Date
- 2019-11-19
- Public Version Status
- New
- Public Device Record Key
- 244e8358-89ed-45ef-94ee-1287dcfd66e9
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34978 | Blood pressure cuff, reusable | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EMIP51000410 | HIBCC |
Customer Contacts
- Phone
- +49814592090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142032 | 000 |