AccessGUDID - DEVICE: Caplugs/Evergreen (00810044206722)

GUDID

Device Identifier (DI) Information

Brand Name: Caplugs/Evergreen
Version or Model: 208-3385-06R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 208-3385-06R
Company Name: CAPlugs

Primary DI Number: 00810044206722
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 098203461 *Terms of Use

Device Description: 5" CHROMATOGRAPHY COLUMN

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?
64980	Fast protein liquid chromatography (FPLC) analyser column IVD	A component of a fast protein liquid chromatography (FPLC) analyser intended to be used to separate the constituents of a clinical specimen based on their protein physical and/or chemical properties. The column is typically in the form of a narrow flow-through tube, prepacked with a column filling (e.g., gel or polymer beads). It is typically made from synthetic polymer materials (e.g., plastic) This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKO	ADSORBENTS, ION-EXCHANGE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b6a0a26-2d85-4115-9eb4-fda441e08e17
Public Version Date: June 10, 2024
Public Version Number: 1
DI Record Publish Date: May 31, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00810044207019 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(716)876-9855 ext: 3241
Email: christine.koch@caplugs.com

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