AccessGUDID - DEVICE: AmnioTest (Nitrazine yellow swab) (10628429001223)

GUDID

Device Identifier (DI) Information

Brand Name: AmnioTest (Nitrazine yellow swab)
Version or Model: PL.901
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.901
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 10628429001223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65199	Amniotic fluid leak detector	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Microwave Radiation

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83190e6e-898c-4e92-aa00-3cbb2d1d4fa7
Public Version Date: January 03, 2023
Public Version Number: 1
DI Record Publish Date: December 26, 2022