AccessGUDID - DEVICE: CUSTOMED (M20890027800)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOMED
Version or Model: 712057052780
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9002780
Company Name: CUSTOMED INC

Primary DI Number: M20890027800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627572217 *Terms of Use

Device Description: DISPOSABLE MUCUS TRAP, 40 ML (CC)

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):	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?
10943	Sputum specimen container IVD	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a sputum specimen for culture, analysis, and/or other investigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	Trap, Sterile Specimen

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Special Storage Condition, Specify: STORE IN A COOL DRY PLACE
Special Storage Condition, Specify: DO NOT USE IF PACKAGE IS OPEN OR DAMAGED

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 40 Milliliter

Device Record Status

Public Device Record Key: 1885575a-e3e1-48dd-a0fc-9c5f4969d7a7
Public Version Date: January 22, 2021
Public Version Number: 3
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M20890027802	50	M20890027800		In Commercial Distribution	50/CS

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 787-622-5151
Email: customer.service@customedhealing.com

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