AccessGUDID - DEVICE: Devon (10884527014743)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31144168
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31144168
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527014743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Sponge Counting Rack for I.V. Pole,Multi-Bag

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
13693	Surgical sponge-counting rack	A device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	STAND, INFUSION

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
Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d677d4d-5cda-44e1-aba0-273ab34ff472
Public Version Date: November 27, 2019
Public Version Number: 3
DI Record Publish Date: June 23, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884527014740	2	10884527014743		In Commercial Distribution	CASE

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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