FDA UDI
In Commercial Distribution
🇺🇸 United States
FLORIDA MEDICAL SALES INC.
DI: 00857444006002
·
Model: FMSI-828
·
FLORIDA MEDICAL SALES INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FLORIDA MEDICAL SALES INC.
- Primary DI
- 00857444006002
- Version / Model
- FMSI-828
- Catalog Number
- H-FMSI- 828
- Company Name
- FLORIDA MEDICAL SALES INC
- Labeler DUNS
- 782049217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6fee26e5-2aea-4d0f-80f5-f4f83355ea6f
Device Description
FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 2 AA ALKALINE BATTERIES, 1 I.D. CARDS.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62149 | Electrocardiographic long-term ambulatory recording support kit | A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10857444006009 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 00857444006002 | GS1 |