FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632143038
·
Model: CL13101
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632143038
- Version / Model
- CL13101
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0f2e0fcf-bff0-45b0-acd9-84e3f0c2302a
Device Description
Clip Alligator Banana Style For 4mm Needle Not Made With Natural Rubber Latex MediChoice
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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 60264 | Multiple physiological parameter simulation kit | A collection of portable devices intended to imitate a variety of physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, and haemoglobin oxygen saturation (SpO2)] and conditions in order to test and calibrate patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. It typically includes a programming unit with a digital display, an ECG attachment unit, a SpO2 simulation unit, and connection cables. This device is intended to be used by a healthcare provider in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885632143038 | GS1 | ||||
| Unit of Use | 60885632143033 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Freezing and Excessive Heat
- Type
- Special Storage Condition, Specify
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Fahrenheit