FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Summit Medical
DI: B346R0011
·
Model: R001
·
DRAGON HEART MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Summit Medical
- Primary DI
- B346R0011
- Version / Model
- R001
- Catalog Number
- 10
- Company Name
- DRAGON HEART MEDICAL, INC.
- Labeler DUNS
- 841522985
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-03
- Public Version
- 2
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- f592e766-4f63-4005-b93c-396ee487f7a5
- Distribution End Date
- 2023-12-31
Device Description
NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42510 | Medical air terminal unit | A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for medical air. It is designed to be mounted to wall-mounted medical supply units, utility supply systems (ceiling pendants), or directly to a wall, and functions as the outlet assembly of a gas pipeline system to which the operator can connect and disconnect a device, typically anaesthesia systems, ventilators, respiratory devices and devices that are powered using this gas type. On disconnection of the medical device from the outlet, it will self seal the gas pipeline system preventing gas leakage to the environment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B346R0011 | HIBCC | ||||
| Package | B346R00129 | HIBCC | 50 | Not in Commercial Distribution | 2023-12-31 |