FDA UDI
In Commercial Distribution
🇺🇸 United States
ROM Plus®, Fetal Membranes Rupture Test
DI: 00814247020420
·
Model: ROM-5000
·
CLINICAL INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ROM Plus®, Fetal Membranes Rupture Test
- Primary DI
- 00814247020420
- Version / Model
- ROM-5000
- Company Name
- CLINICAL INNOVATIONS, LLC
- Labeler DUNS
- 809524291
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- 6d42ffab-395f-483b-ae6b-fca2c67097e2
Device Description
ROM Plus® Complete Test Kit
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | Clinical Chemistry | 862.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42923 | Amniotic fluid leak detection device IVD | An in vitro diagnostic device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20814247020424 | GS1 | 4 | In Commercial Distribution | ||
| Package | 10814247020427 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00814247020420 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110605 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place. Do not freeze.