AccessGUDID - DEVICE: Fisherbrand Serum Filter (10817139020413)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand Serum Filter
Version or Model: Standard Model
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02-681-55
Company Name: POREX CORPORATION

Primary DI Number: 10817139020413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 186972733 *Terms of Use

Device Description: 16mm x 2 1/2" Fisherbrand Serum 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":	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?
57895	Evacuated blood collection tube IVD, no additive/metal-free	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum with no additive and free of any metals. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations including trace elements, serology, and toxicology). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GIM	Tubes, Vacuum Sample, With Anticoagulant

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e335418f-94f3-4dd4-bc65-36d4b3d99ab2
Public Version Date: November 10, 2021
Public Version Number: 3
DI Record Publish Date: September 14, 2016