AccessGUDID - DEVICE: Mucous Specimen Trap (00801741049415)

GUDID

Device Identifier (DI) Information

Brand Name: Mucous Specimen Trap
Version or Model: 0045860
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0045860
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741049415
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Mucous Specimen Trap, 80cc

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?
65196	General specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 80 Milliliter

Device Record Status

Public Device Record Key: 060f6140-25fb-47d3-b26b-e226f0ce40ae
Public Version Date: August 01, 2023
Public Version Number: 2
DI Record Publish Date: September 22, 2020