AccessGUDID - DEVICE: NasalCEASE® (10860008863338)

GUDID

Device Identifier (DI) Information

Brand Name: NasalCEASE®
Version or Model: CAT NAS-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT NAS-5
Company Name: Carencease Healthcare LLC

Primary DI Number: 10860008863338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 080452143 *Terms of Use

Device Description: NasalCease, Sterile, 5 Starter Pack

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):	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?
65150	Nasal haemostatic plug	A small piece of material intended to be inserted into the nose to apply pressure within the nasal cavity to control nose bleeding (epistaxis) and provide a barrier in the nostril to prevent blood drip. It is made of either an expandable foam material which may provide some degree of blood absorption, or fatty plant-derived materials which melt over time lubricating the nostril to prevent further damage when the device is removed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug
EMX	Balloon, Epistaxis

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: .75 Inch
Length: 1.5 Inch

Device Record Status

Public Device Record Key: fceff1a0-803b-4afa-8abe-46d5a1b23165
Public Version Date: December 18, 2024
Public Version Number: 1
DI Record Publish Date: December 10, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30860008863332	36	10860008863338		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00860008863331 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 585-624-7540
Email: info@catalina-healthcare.com

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