FDA UDI
In Commercial Distribution
🇺🇸 United States
NIBP Cuffs
DI: 00884838114678
·
Model: COMFORT CARE CUFF, SMALL ADULT
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NIBP Cuffs
- Primary DI
- 00884838114678
- Version / Model
- COMFORT CARE CUFF, SMALL ADULT
- Catalog Number
- M1573A
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-23
- Public Version
- 2
- Public Version Date
- 2025-09-16
- Public Version Status
- Update
- Public Device Record Key
- 473ae16f-8940-4128-975e-09fb432a1e22
Device Description
Long-life reusable NIBP cuff/small adult Premium quality individual cuff w/fluid cap and instructions. For limb circumference 20.5-28cm. Polyurethane bladder, hose, cover. No latex or PVC.
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00884838114678 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Circumference 28 Centimetre | ||
| Circumference | 28.0000 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius