REEF HP
- Primary DI
- 08033477048970
- Brand
- REEF HP
- Company
- MEDTRONIC, INC.
- Model
- REE080030082
- Device description
- Cath REE080030082 REEUS 08.00 L030UL0800
- Published
- 2016-06-19
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
medtronic.comProduct Codes
| Code | Name |
|---|---|
| LIT | Catheter, angioplasty, peripheral, transluminal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08033477048970 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08033477048970 | 08033477048970 | 8033477048970 |
GMDN Terms
| Term | Definition |
|---|---|
| Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Length | 30 | Millimeter |
| Outer Diameter | 8 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
Regulatory Flags
- DUNS number
- 006261481
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00613994963826 | NIH™ | 008761 | 2016-07-24 | |
| 00613994964274 | NIH™ Cardio-Marker | 010011 | 2016-06-10 | |
| 00613994964540 | Lehman™ | 001259 | 2016-06-05 | |
| 00613994964564 | Lehman™ | 001263 | 2016-06-05 | |
| 00613994964120 | Sones™ Brachial | 990707 | 2016-06-05 | |
| 00613994964748 | Goodale-Lubin™ | 007460 | 2016-06-05 | |
| 00681490860659 | DLP | CB14017 | 2016-05-22 | |
| 00199150006038 | N/A | TM91D0 | 2026-05-23 | |
| 00199150080649 | NA | BB12S94R5 | 2026-05-23 | |
| 00199150080694 | NA | BB12V43R1 | 2026-05-23 | |
| 00199150080700 | NA | BB11E27R3 | 2026-05-23 | |
| 00199150081004 | NA | BB11J58R8 | 2026-05-23 | |
| 00199150081011 | NA | BB12T50R3 | 2026-05-23 | |
| 00199150081035 | NA | BB7E31R34 | 2026-05-22 | |
| 00199150081042 | NA | 12D63R2 | 2026-05-22 | |
| 00199150081066 | NA | 4J31R1 | 2026-05-23 | |
| 00199150081707 | NA | BB11J59R9 | 2026-05-22 | |
| 00199150081714 | NA | BB11U73R2 | 2026-05-23 | |
| 00199150081738 | NA | BB11J16R3 | 2026-05-22 | |
| 00199150081745 | NA | 9M68R1 | 2026-05-23 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07640119558639 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558646 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558653 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558660 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558677 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558684 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558691 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558707 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558714 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558721 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558738 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558745 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558752 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558769 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558776 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558783 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558790 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558806 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558813 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558820 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558837 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558844 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558851 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558868 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558875 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558882 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558899 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558905 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558912 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558929 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |