AccessGUDID - DEVICE: AMD-RITMED (10686864048036)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: 2213-BL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2213-BL
Company Name: AMD Medicom Inc

Primary DI Number: 10686864048036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS

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):	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?
61453	Surgical sponge-counting tray	A device in the form of a tray intended to be used in the operating room (OR) to store and 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 tray with individual sections; it may be weighed following sponge/swab collection to calculate blood loss. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWH	Counter, sponge, surgical

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: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed0622e6-472b-47d5-8a58-2fd0df7692f4
Public Version Date: July 29, 2022
Public Version Number: 3
DI Record Publish Date: January 16, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20686864048033	8	10686864048036		In Commercial Distribution	Outer Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00686864048039 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(514)636-6262
Email: mkansou@medicom.ca

Phone: +1(514)636-6262 ext: 2309
Email: mdasilva@medicom.ca

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