FDA UDI
In Commercial Distribution
🇺🇸 United States
Safety Adapter
DI: 00813079020134
·
Model: ADAP I
·
REMINGTON MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Safety Adapter
- Primary DI
- 00813079020134
- Version / Model
- ADAP I
- Catalog Number
- ADAP I
- Company Name
- REMINGTON MEDICAL, INC.
- Labeler DUNS
- 788472314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2018-11-06
- Public Version Status
- Update
- Public Device Record Key
- aa47c917-b153-4b9b-86a4-a64eaabb3d43
Device Description
The ADAP 1 is designed to interface between the recessed pin connectors used with Remington's cable models S-101-97, S-201-97, and FL-601-97, and the old models of external pulse generators (EPG) [old model is the acceptance of exposed 2mm pins]. Also, ADAP I is designed to be used with pacing system analyzers that have sockets that accept 2mm pins and 31.25mm separation between pins.
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 47143 | Electrical-only medical device connection cable, single-use | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813079020134 | GS1 | ||||
| Package | 10813079020131 | GS1 | Shipping Carton | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)989-0057
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 15.204 | Square inch |