FDA UDI
Not in Commercial Distribution
🇺🇸 United States
9Line
DI: G0963PS0300
·
Model: 3PS-030
·
Rising Eagle Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- 9Line
- Primary DI
- G0963PS0300
- Version / Model
- 3PS-030
- Catalog Number
- 3PS-030
- Company Name
- Rising Eagle Medical LLC
- Labeler DUNS
- 080145608
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-21
- Public Version
- 3
- Public Version Date
- 2024-10-07
- Public Version Status
- Update
- Public Device Record Key
- 2a4f498f-a033-48e9-9cca-b2e064fa9361
- Distribution End Date
- 2024-06-05
Device Description
3 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61821 | Electrocardiographic lead set, single-use | A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G0963PS0305 | HIBCC | BX | 50 | Not in Commercial Distribution | 2024-06-05 |
| Primary | G0963PS0300 | HIBCC |
Customer Contacts
- Phone
- 888-399-0119
- [email protected]