FDA UDI
In Commercial Distribution
🇺🇸 United States
Amnicators
DI: 05060259071300
·
Model: N/a
·
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Amnicators
- Primary DI
- 05060259071300
- Version / Model
- N/a
- Catalog Number
- MWAM5
- Company Name
- MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
- Labeler DUNS
- 216096750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 1
- Public Version Date
- 2023-10-13
- Public Version Status
- New
- Public Device Record Key
- 74fb8dd0-28af-4d09-b92b-1e0de84d0045
Device Description
Amniotic Fluid Indicator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | Obstetrics/Gynecology | 884.1550 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 25060259071304 | GS1 | ||||
| Primary | 05060259071300 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius