FDA UDI
In Commercial Distribution
🇺🇸 United States
Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L
DI: 00899054002845
·
Model: HAF-3SHS
·
KDL MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L
- Primary DI
- 00899054002845
- Version / Model
- HAF-3SHS
- Company Name
- KDL MEDICAL, INC.
- Labeler DUNS
- 791048924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-02-10
- Public Version
- 1
- Public Version Date
- 2025-02-18
- Public Version Status
- New
- Public Device Record Key
- 5f0ef2d7-60f5-4782-bcbc-48b1915ec5d2
Device Description
Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62379 | Surgical instrument assist arm system, manually-adjusted | A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10899054002842 | GS1 | ||||
| Primary | 00899054002845 | GS1 |
Customer Contacts
- Phone
- 972-783-7005
- [email protected]