FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CUFFF,CHILD,MRI,COLDER CONN
DI: 00884838045194
·
Model: Cuff, Child, MRI, Colder Conn
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CUFFF,CHILD,MRI,COLDER CONN
- Primary DI
- 00884838045194
- Version / Model
- Cuff, Child, MRI, Colder Conn
- Catalog Number
- 989803169441
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-22
- Public Version
- 8
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 77096d3e-a0e9-44ac-b662-1285e5a635dd
- Distribution End Date
- 2022-12-15
Device Description
CUFFF,CHILD,MRI,COLDER CONN
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
- 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 |
|---|---|---|---|---|
| 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 | 00884838045194 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]