AccessGUDID - DEVICE: Actim PROM (06430030990714)

GUDID

Device Identifier (DI) Information

Brand Name: Actim PROM
Version or Model: 30821ETUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Actim Oy

Primary DI Number: 06430030990714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368646046 *Terms of Use

Device Description: Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
64054	Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of insulin-like growth factor binding protein 1 (IGFBP-1) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the detection of foetal membrane rupture in pregnancy and/or to help predict the risk of preterm or imminent delivery. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123986	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c9fad6a-4b68-4a70-9b02-8a929f7c9e57
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: February 28, 2019