MiniGuard Arterial Safety Valve, Non-Sterile
- Primary DI
- 10634624482002
- Brand
- MiniGuard Arterial Safety Valve, Non-Sterile
- Company
- QUEST MEDICAL INC
- Model
- 4008200
- Catalog number
- 4008200
- Published
- 2019-01-18
- 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
Product Codes#
| Code | Name |
|---|---|
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | Cardiovascular | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20634624482009 | Package | GS1 | 5 | Not in Commercial Distribution |
| 10634624482002 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20634624482009 | 20634624482009 |
| 10634624482002 | 10634624482002 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cardiopulmonary bypass system valve, unidirectional flow/pressure control | A sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device. |
Regulatory Flags#
- DUNS number
- 041810693
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00634624090651 | 6" (15 cm) Microbore Extension Set with Clamp | 9065 | 2017-02-13 | |
| 00634624092501 | 7 in (18cm) Y-Extension Set w/ 2 check valves | 9250 | 9250 | 2016-07-26 |
| 00634624095410 | 44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site | 9541 | 9541 | 2016-07-26 |
| 00634624095434 | Q2 Checkmate Extension Set | 9543 | 2016-06-10 | |
| 00634624101159 | Q2 IV Administration Set | ASV10115 | 2022-12-06 | |
| 00634624101258 | Q2 IV Administration Set | ASV10125 | 2022-12-06 | |
| 00634624101302 | Q2 IV Administration Set | ASV10130 | 2022-12-06 | |
| 00634624601253 | Q2 IV Administration Set | ASV60125 | 2022-12-06 | |
| 00634624621015 | Precision Delivery IV Extension Set | PD60 | 2021-02-05 | |
| 00634624621022 | Precision Delivery IV Extension Set | PD60F | 2021-02-05 | |
| 00634624621039 | Precision Delivery IV Extension Set | PDM60 | 2021-02-05 | |
| 00634624621046 | Precision Delivery IV Extension Set | PDM60F | 2021-02-05 | |
| 00634624621053 | Precision Delivery IV Extension Set | PDMV60 | 2021-02-05 | |
| 00634624621060 | Precision Delivery IV Extension Set | PDMV60F | 2021-02-05 | |
| 00634624621077 | Precision Delivery IV Extension Set | PDV06 | 2021-02-05 | |
| 00634624621084 | Precision Delivery IV Extension Set | PDV06F | 2021-02-05 | |
| 00634624621091 | Precision Delivery IV Extension Set | PDV60 | 2021-02-05 | |
| 00634624621107 | Precision Delivery IV Extension Set | PDV60F | 2021-02-05 | |
| 00634624621114 | Precision Delivery Trifurcated IV Extension Set | PDT05 | 2021-02-05 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10634624481005 | MiniGuard Arterial Safety Valve | QUEST MEDICAL INC | MJJ | 2019-01-18 |
| 10634624472003 | RetroGuard Arterial Safety Valve | QUEST MEDICAL INC | MJJ | 2016-06-06 |
| 20634624472000 | RetroGuard Arterial Safety Valve | QUEST MEDICAL INC | MJJ | 2016-06-06 |
| 00634624471009 | RetroGuard Arterial Safety Valve | QUEST MEDICAL INC | MJJ | 2016-06-03 |
| 20634624471003 | RetroGuard Arterial Safety Valve | QUEST MEDICAL INC | MJJ | 2016-06-03 |
| 00803622123412 | Vacuum Relief Check Valve | LIVANOVA USA, INC. | MJJ | 2015-05-01 |
| 10803622123419 | Vacuum Relief Check Valve | LIVANOVA USA, INC. | MJJ | 2015-05-01 |