DRAP ENLISTED MEDICAL DEVICE
Mobile Power Unit-107754/ (107758)/(107758UK) (Accessories used for Heartmate II (LVAS) is enlisted with DRAP under number MDIE-0000033 as a Class A (low risk) medical device, imported. The listed holder is ACP Systems. Its listed renewal date (3 Dec 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIE-0000033
DRAP enlisted Class A list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00001
| Device | Mobile Power Unit-107754/ (107758)/(107758UK) (Accessories used for Heartmate II (LVAS) |
|---|---|
| Class | A |
| Listed holder | ACP Systems |
| Holder address | 13 & 23 Naval Fleet Club, Iqbal (SJ) Shaheed Road, Karachi, Godown: Same as above |
| Manufacturing site | M/s THORATEC CORP 6035 Stoneridge Dr PLEASANTON, CA USA |
| Issued | 4 Dec 2019 |
| Renewal date | 3 Dec 2024 |
| Licence | ELI-00001 |
Specifications
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Screened 5 Oct 2026, 11:25 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIE-0000034 | Shower Bag ( Pocket Controller) -104232 (Acessories (Paitent Wearable) | Class A |
| MDIE-0000035 | Consolidated Bag-Pocket Controller 14V Battery, Right -104233 (Accessories used for Heartmate II (LVAS) | Class A |
| MDIE-0000036 | Universal Battery Charger -1440 (103869) External Component used for Heartmate II (LVAS) | Class A |
| MDIE-0000037 | Thoratec Heart Mate II System Controller (Pocket Controller with EBB)-106762 (106017) | Class A |
| MDIE-0000038 | Heart Mate 14 Volt Li-Ion Battery Clip Set2865 | Class A |
| MDIE-0000039 | HeartMate 3 LVAS System Controller with EBB 106531US/ (106531INT) | Class A |
| MDIE-0000040 | 14 Volt Li-Ion Battery Set-2456 | Class A |
| MDIE-0000272 | DeBakey Forceps Surgical Reusable (non Sterile) Instruments | Class A |
| MDIE-0000273 | Thoracoscopic Knot Tier/Pusher | Class A |
| MDIE-0000274 | MIS Clip Applier | Class A |
| MDIE-0000275 | MIS Scissors | Class A |
| MDIE-0000276 | Bard-Parker handle | Class A |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.
