BlueFIRE™
- Primary DI
- 10884450413484
- Brand
- BlueFIRE™
- Company
- Merit Medical Systems, Inc.
- Model
- 00884450413487
- Catalog number
- IN10802
- Published
- 2024-01-05
- Public version status
- New
- Distribution status
- 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 |
|---|
| PTM | Syringe, Balloon Inflation, Exempt |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PTM | Syringe, Balloon Inflation, Exempt | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10884450413484 | Package | GS1 | 5 | In Commercial Distribution |
| 20884450413481 | Package | GS1 | 2 | In Commercial Distribution |
| 00884450413487 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10884450413484 | 10884450413484 | | |
| 20884450413481 | 20884450413481 | | |
| 00884450413487 | 00884450413487 | 884450413487 | 0884450413487 |
GMDN Terms
| Term | Definition |
|---|
| Catheter/overtube balloon inflator, single-use | A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device. |
Regulatory Flags
- DUNS number
- 184763290
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
| 30197344203479 | NAMIC | MEDLINE INDUSTRIES, INC. | PTM | 2026-03-16 |
| 20884450440616 | basixTOUCH™ | Merit Medical Systems, Inc. | PTM | 2026-02-20 |
| 40889942546351 | Namic | MEDLINE INDUSTRIES, INC. | PTM | 2025-12-18 |
| 10724995244535 | Lumiflex | US Endoscopy | PTM | 2025-08-19 |
| 10884450860370 | BIG60™ | Merit Medical Systems, Inc. | PTM | 2025-05-31 |
| 10859500005162 | StopLock | FEMASYS INC. | PTM | 2025-05-02 |
| 00859500005165 | StopLock | FEMASYS INC. | PTM | 2025-05-02 |
| 30859500005166 | StopLock | FEMASYS INC. | PTM | 2025-05-02 |
| 10884450860110 | basixCOMPAK™ | Merit Medical Systems, Inc. | PTM | 2025-04-23 |
| 10884450860103 | basixCOMPAK™ | Merit Medical Systems, Inc. | PTM | 2025-04-21 |
| 10884450860950 | basixCOMPAK™ | Merit Medical Systems, Inc. | PTM | 2025-04-15 |
| 20884450621374 | basixTOUCH™ | Merit Medical Systems, Inc. | PTM | 2025-01-15 |
| 10884450621391 | basixTOUCH™ | Merit Medical Systems, Inc. | PTM | 2025-01-15 |
| 00884450822517 | basixSKY™ | Merit Medical Systems, Inc. | PTM | 2024-12-28 |
| 20197344104939 | NAMIC | MEDLINE INDUSTRIES, INC. | PTM | 2024-09-09 |
| 16970057578429 | Balloon Inflators | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | PTM | 2024-08-20 |
| 06971162817789 | Balloon inflation device | Tianck Medical Co., Ltd. | PTM | 2024-08-02 |
| 08800026501558 | GENOSS Inflator B30 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08800026501565 | GENOSS Inflator B30 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08800026507598 | GENOSS Inflator B30 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08800026507611 | GENOSS Inflator B40 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08800026507635 | GENOSS Inflator B40 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08800026512752 | GENOSS Inflator B40 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08800026530329 | GENOSS Inflator B30 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08809324765433 | GENOSS Inflator B30 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08809552962918 | GENOSS Inflator B40 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 08809552962925 | GENOSS Inflator B40 | GENOSS CO., Ltd. | PTM | 2024-06-18 |
| 00884450822524 | basixSKY™ | Merit Medical Systems, Inc. | PTM | 2024-06-18 |
| 20197344013781 | NAMIC | MEDLINE INDUSTRIES, INC. | PTM | 2024-06-14 |
| 00884450822500 | basixSKY™ | Merit Medical Systems, Inc. | PTM | 2024-05-23 |