AccessGUDID - DEVICE: ROM Plus®, Fetal Membranes Rupture Test (00814247020437)

GUDID

Device Identifier (DI) Information

Brand Name: ROM Plus®, Fetal Membranes Rupture Test
Version or Model: ROM-5025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CLINICAL INNOVATIONS, LLC

Primary DI Number: 00814247020437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809524291 *Terms of Use

Device Description: ROM Plus® Complete Kit Fetal Membranes Rupture Test

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQM	Immunoassay For Detection Of Amniotic Fluid Protein(S).

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110605	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place. Do not freeze.
Storage Environment Temperature: between 4 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64c9e25d-ce8f-4194-86f8-d48976cff5b6
Public Version Date: November 19, 2020
Public Version Number: 4
DI Record Publish Date: September 01, 2016