Amnicators MWAM5

GUDID 25060259071304

Amniotic Fluid Indicator

MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED

Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD Amniotic fluid leak detection device IVD

• Primary Device ID: 25060259071304
• NIH Device Record Key: 74fb8dd0-28af-4d09-b92b-1e0de84d0045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amnicators
• Version Model Number: N/a
• Catalog Number: MWAM5
• Company DUNS: 216096750
• Company Name: MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060259071300 [Primary]
GS1	25060259071304 [Unit of Use]

FDA Product Code

• HIO: Sampler, Amniotic Fluid (Amniocentesis Tray)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [Amnicators]

• 05060259071317: Amnicator - For the Detection of PROM
• 25060259071304: Amniotic Fluid Indicator