AccessGUDID - DEVICE: International Filter Products, doing business as IFP Medical (00860013851279)

GUDID

Device Identifier (DI) Information

Brand Name: International Filter Products, doing business as IFP Medical
Version or Model: IFP-17G-0500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IFP-17G-0500
Company Name: INTERNATIONAL FILTER PRODUCTS, INC.

Primary DI Number: 00860013851279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030220053 *Terms of Use

Device Description: Sterile Empty EVA Pillow Bag, 5000 mL, 3 Ports, With One LF Port

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?
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPE	Container, I.V.

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e99ab06-85d5-4210-ab56-0c213969b2a0
Public Version Date: May 19, 2025
Public Version Number: 1
DI Record Publish Date: May 09, 2025