FDA UDI
In Commercial Distribution
🇺🇸 United States
NIBP Cuffs
DI: 20884838114863
·
Model: GENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- NIBP Cuffs
- Primary DI
- 20884838114863
- Version / Model
- GENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE
- Catalog Number
- M4578B
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-04-01
- Public Version
- 2
- Public Version Date
- 2025-10-10
- Public Version Status
- Update
- Public Device Record Key
- f886da95-4fab-46c6-94f6-98bb3c298670
Device Description
Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition
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 |
|---|---|---|---|---|
| OED | Antimicrobial Blood Pressure Cuff | Cardiovascular | 870.1120 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00884838114869 | GS1 | ||||
| Primary | 20884838114863 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 45.000 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity