DLP®
- Primary DI
- 00763000946500
- Brand
- DLP®
- Company
- MEDTRONIC, INC.
- Model
- 61000
- Device description
- PRESSURE DISPLAY SET W/STOPCOCK 45 INCH
- Published
- 2024-07-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
medtronic.comProduct Codes#
| Code | Name |
|---|---|
| DXS | GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K113235 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20763000946504 | Primary | GS1 | 0 | |
| 00763000946500 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 20763000946504 | 20763000946504 | ||
| 00763000946500 | 00763000946500 | 763000946500 | 0763000946500 |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 114.3 | Centimeter |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
Regulatory Flags#
- DUNS number
- 006261481
- Device count
- 10
- 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
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00643169705753 | MyCareLink™ | 24950JLQ | 2016-05-28 | |
| 00763000354466 | Symplicity Spyral™ | RDN016 | 2023-11-30 | |
| 00613994391551 | NA | 6207-S5 | 2017-01-03 | |
| 00613994391568 | NA | 6208-S5 | 2017-01-03 | |
| 00613994391575 | NA | 6209-S5 | 2017-01-03 | |
| 00613994391582 | NA | 6210-S5 | 2017-01-03 | |
| 00613994397829 | NA | 6211-S5 | 2017-01-03 | |
| 00643169002913 | Stretch™ Insertion Tool | 006073 | 2016-07-02 | |
| 00643169013964 | NA | 208211 | 2017-02-02 | |
| 00643169013988 | NA | 207223 | 2017-02-03 | |
| 00643169013995 | NA | 207211A | 2017-02-02 | |
| 00643169014008 | NA | 207211 | 2017-02-02 | |
| 00643169014022 | NA | 206223 | 2017-02-03 | |
| 00643169014039 | NA | 206211A | 2017-02-02 | |
| 00643169014046 | NA | 206211 | 2017-02-02 | |
| 00643169014053 | NA | 205211A | 2017-02-02 | |
| 00643169014060 | NA | 205211 | 2017-02-02 | |
| 00643169014077 | INPUT™ TS | 091102A | 2017-02-02 | |
| 00643169014084 | INPUT™ TS | 091101A | 2017-02-03 | |
| 00643169014091 | INPUT™ TS | 090037A | 2017-02-02 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04250413406470 | ABPMpro cuff for right arm | SOMNOmedics AG | DXS | 2026-07-07 |
| 20763000946504 | DLP® | MEDTRONIC, INC. | DXS | 2024-07-18 |
| 20643169880959 | DLP® | MEDTRONIC, INC. | DXS | 2019-03-03 |
| 20613994846604 | DLP® | MEDTRONIC, INC. | DXS | 2016-06-13 |
| 20613994846628 | DLP® | MEDTRONIC, INC. | DXS | 2016-06-13 |
| 20613994846642 | DLP® | MEDTRONIC, INC. | DXS | 2016-06-13 |
| 20613994846666 | DLP® | MEDTRONIC, INC. | DXS | 2016-06-13 |
| 00643169200999 | NA | MEDTRONIC, INC. | DXS | 2016-04-28 |
| B0663014000000 | PRESSURE GAUGE ISOLATOR KIT | NOVOSCI CORP. | DXS | 2015-10-09 |
| B0663014000007 | PRESSURE GUAGE ISOLATOR KIT | NOVOSCI CORP. | DXS | 2015-10-09 |