FDA UDI
In Commercial Distribution
🇺🇸 United States
ACHIEVE ADVANCE™
DI: 00643169590984
·
Model: 2ACH20
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACHIEVE ADVANCE™
- Primary DI
- 00643169590984
- Version / Model
- 2ACH20
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b87beecb-e241-4ebd-8337-bd65ea31e23d
Device Description
CATHETER 2ACH20 20MM DIAMETER US
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | Cardiovascular | 870.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46355 | Cardiac mapping catheter, percutaneous, single-use | A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169590984 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter diameter 1.1 mm (3.3 Fr) | ||
| Device Size Text, specify | Loop size 20 mm | ||
| Device Size Text, specify | Electrode spacing 6 mm | ||
| Length | 165.0 | Centimeter | |
| Device Size Text, specify | Effective length 146 cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -31 – 136 Degrees Fahrenheit