AccessGUDID - DEVICE: blox (00814088020726)

GUDID

Device Identifier (DI) Information

Brand Name: blox
Version or Model: BLX-9501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: IVWATCH, LLC

Primary DI Number: 00814088020726
Issuing Agency: GS1
Commercial Distribution End Date: June 12, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 057028415 *Terms of Use

Device Description: Surgical N95 Respirator

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":	Yes
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?
57794	Surgical/medical respirator, non-antimicrobial, single-use	A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSH	Respirator, Surgical

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: No
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: 58232524-77ef-4f1f-a3d4-055fb4453a2e
Public Version Date: June 18, 2025
Public Version Number: 3
DI Record Publish Date: November 11, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00814088020788	50	00814088020726	2025-06-12	Not in Commercial Distribution	Box
00814088020795	10	00814088020726	2025-06-12	Not in Commercial Distribution	Pouch
00814088020818	6	00814088020788	2025-06-12	Not in Commercial Distribution	Case
00814088020801	24	00814088020795	2025-06-12	Not in Commercial Distribution	Case
10814088020815	56	00814088020818	2025-06-12	Not in Commercial Distribution	Pallet

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

Customer Contact

[?]

Phone: (855) 489-2824
Email: technicalsupport@ivwatch.com

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