FDA UDI
Not in Commercial Distribution
🇺🇸 United States
STATCORP MEDICAL
DI: 10841522103957
·
Model: STATCORP
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STATCORP MEDICAL
- Primary DI
- 10841522103957
- Version / Model
- STATCORP
- Catalog Number
- 015-1826
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-06
- Public Version
- 5
- Public Version Date
- 2019-07-22
- Public Version Status
- Update
- Public Device Record Key
- f430bdba-86b0-4306-b9d8-35160250d5ed
- Distribution End Date
- 2018-05-15
Device Description
ABP CUFF,SPACELABS,1T,SMALL ADULT,SINGLE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| DSI | DETECTOR AND ALARM, ARRHYTHMIA | Cardiovascular | 870.1025 | 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 |
|---|---|---|---|---|---|---|
| Package | 30841522103951 | GS1 | BX | 20 | Not in Commercial Distribution | 2018-05-15 |
| Primary | 10841522103957 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103142 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity