FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cardiohelp
DI: 04058863084336
·
Model: Mobile Holder HKH 8860
·
Maquet Cardiopulmonary AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cardiohelp
- Primary DI
- 04058863084336
- Version / Model
- Mobile Holder HKH 8860
- Catalog Number
- 70107.3079
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-01
- Public Version
- 4
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 36a80d22-16a7-4375-b745-7b8d14760738
- Distribution End Date
- 2024-09-25
Device Description
CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP protection cover.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DTQ | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35954 | Medical device rail | A device in the form of a narrow bar designed to be fixed on the wall for mounting and organizing medical devices [e.g., in hospital wards, treatment rooms, intensive care units (ICU)]; the equipment to be supported is not included. It may be used in conjunction with clamps and/or poles. It is available in various lengths. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04058863084336 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102726 | 000 |