AccessGUDID - DEVICE: PolyMem (10735471053350)

GUDID

Device Identifier (DI) Information

Brand Name: PolyMem
Version or Model: Shapes
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5335
Company Name: FERRIS MFG. CORP.

Primary DI Number: 10735471053350
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084733682 *Terms of Use

Device Description: 3.5" x 3.5" Shapes by PolyMem Tube Dressing

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
15624	Tracheostomy tube dressing	A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMF	Bandage, Liquid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: less than 30 Degrees Celsius
Special Storage Condition, Specify: Excursions permitted less than 55 degrees celcius but should be minimized

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3.5 in. x 3.5 in.

Device Record Status

Public Device Record Key: 793d719c-f731-4cd5-aad8-9dc91d42b859
Public Version Date: January 22, 2021
Public Version Number: 2
DI Record Publish Date: August 31, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20735471053357	15	10735471053350		In Commercial Distribution	Box
30735471053354	2	20735471053357		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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8007659636
Email: info@polymem.com

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