FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632116629
·
Model: MC1710H
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632116629
- Version / Model
- MC1710H
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-06-15
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- ea6fb5b3-4270-476e-84e8-e8e3f7735258
Device Description
Electrode Defibrillation Electrocardiogram Radiolucent Vinyl Laminated Foam Conductive Foil Adhesive Hydrogel Pacing Equal To Phillips Dp2 Amp Dp6 Amp M3713A Adult Not Made With Natural Rubber Latex MediChoice
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MLN | Electrode, electrocardiograph, multi-function | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11130 | Electrode conductive skin pad, single-use | A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632116627 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10885632116629 | GS1 | ||||
| Unit of Use | 20885632116626 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at over 68 degrees F for greater than four monthes
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 104 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify