AccessGUDID - DEVICE: NA (00085412476551)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: H93835
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: H93835
Company Name: BAXTER CORPORATION ENGLEWOOD

Primary DI Number: 00085412476551
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 078383477 *Terms of Use

Device Description: Sterile 0.2 Micron Filter

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?
15283	Laboratory syringe filter	A sterile device used in combination with certain kinds of laboratory syringes to provide filtration of a sample typically for biological molecule isolation (ultrafiltration), removal of particulates, or for the moving phase of a chromatograph (microfiltration). This device typically consists of a membrane sealed within a housing with inlet and outlet connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHI	Set, i.V. Fluid transfer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K900585	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Pore Size: 0.2 Micrometer

Device Record Status

Public Device Record Key: 8c2a1c0c-b76f-4396-aaf3-fdcd4cae2978
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016