pH Indicator Paper Nitrazine Paper
McKesson - ph4575
Device Description
A 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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LNW
Device Name: Paper, Obstetric Ph
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1550
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00612479268777
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00612479268760
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 00612479268760
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 00612479268784
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00612479268777
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case