FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10888551007146
·
Model: BOS20S
·
STERILMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 10888551007146
- Version / Model
- BOS20S
- Catalog Number
- BOS20S
- Company Name
- STERILMED, INC.
- Labeler DUNS
- 175899459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2019-08-14
- Public Version Status
- Update
- Public Device Record Key
- 8406c7a5-71e6-4827-8daa-0015966fe6b5
Device Description
EP CABLE 20 POLE FEMALE QUICK CONNECT TO 20 PINS 2MM CONDUCTORS BLACK
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
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NLH | CATHETER, RECORDING, ELECTRODE, REPROCESSED | Cardiovascular | 870.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46429 | Electrical-only medical device connection cable, reprocessed | 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. This is a single-use device previously used that has been reprocessed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888551007146 | GS1 |
Customer Contacts
- Phone
- +1(888)541-0078
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101789 | 000 |