FDA UDI
In Commercial Distribution
🇺🇸 United States
PARA-AID
DI: 00819221012002
·
Model: 0001
·
McUre Health Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PARA-AID
- Primary DI
- 00819221012002
- Version / Model
- 0001
- Company Name
- McUre Health Solutions, Inc.
- Labeler DUNS
- 053034873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b639ca63-c18f-4466-aa7e-618e58d358d4
Device Description
Pregnancy Test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60260 | Foetal/maternal multiple physiological parameter simulation kit | A collection of portable devices intended to imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy (e.g., TOCO, uterine and foetal heart activity) in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. It typically includes a foetal/maternal multiple physiological parameter simulator, a foetal heart simulator, 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 | 00819221012002 | GS1 |
Customer Contacts
- Phone
- 6268399001
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit