FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MABIS
DI: 00767056100152
·
Model: 01-100-015
·
D-M-S HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MABIS
- Primary DI
- 00767056100152
- Version / Model
- 01-100-015
- Catalog Number
- 01-100-015
- Company Name
- D-M-S HOLDINGS, INC.
- Labeler DUNS
- 062028220
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- e06f95ab-25e3-4775-ad4e-2d10b46659ba
- Distribution End Date
- 2023-05-08
Device Description
SIGNATURE SPHYG CHILD WITH BLUE NYLON CUFF
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16156 | Aneroid manual sphygmomanometer | A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10767056100159 | GS1 | Master Carton | 40 | Not in Commercial Distribution | 2023-05-08 |
| Primary | 00767056100152 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942543 | 000 |