FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Summit International
DI: B346R0021
·
Model: R002
·
DRAGON HEART MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Summit International
- Primary DI
- B346R0021
- Version / Model
- R002
- Catalog Number
- R002
- 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
- 2021-05-03
- Public Version
- 3
- Public Version Date
- 2024-04-30
- Public Version Status
- Update
- Public Device Record Key
- a164fc6f-6794-4da6-b9b4-cf8039b5f13b
- Distribution End Date
- 2024-04-30
Device Description
Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution vials. Indicated to serve as a connecting port between IV bag and external IV line.
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 36244 | Electronic gravity infusion controller administration set | A collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B346R0021 | HIBCC |