AccessGUDID - DEVICE: P&P Medical Surgical LLC (G026020001)

GUDID

Device Identifier (DI) Information

Brand Name: P&P Medical Surgical LLC
Version or Model: 02000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: P&P Medical Surgical LLC

Primary DI Number: G026020001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022925151 *Terms of Use

Device Description: Disposable Probe Covers Lens Filters Made of Closed-Cell Foam Laminated with Sheet of High Density Polyethylene Plastic Film Fit Electronic Thermometer Box of 200

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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
No Device Sizes

Device Record Status

Public Device Record Key: ae039542-60c8-46d9-8dcf-71c536114d84
Public Version Date: February 18, 2022
Public Version Number: 1
DI Record Publish Date: February 10, 2022