AccessGUDID - DEVICE: O2-MAX (00841470100148)

GUDID

Device Identifier (DI) Information

Brand Name: O2-MAX
Version or Model: 313-8201-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULMODYNE INC

Primary DI Number: 00841470100148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030619483 *Terms of Use

Device Description: No description.

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):	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?
64810	In-line CPAP gas flow management unit, adjustable	A portable non-electronic device intended to mix ambient air with compressed oxygen (O2) to generate a flow of oxygen rich air to a patient with adjustable inspired oxygen concentration (FiO2) [e.g., 28-100%] and adjustable flow rate, for continuous positive airway pressure (CPAP) with oxygen, during noninvasive and invasive ventilation (i.e., capable of both). Also known as a CPAP flow generator, it includes an oxygen supply connection, ambient air inlet, patient outlet, and controls for adjustment of both flow rate and FiO2. CPAP pressure is defined by the PEEP valve used with this device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYE	Attachment, Breathing, Positive End Expiratory Pressure

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: 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: 7bcb70d9-5f93-480b-bc47-8b4641305428
Public Version Date: April 21, 2025
Public Version Number: 1
DI Record Publish Date: April 12, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10841470100145	10	00841470100148		In Commercial Distribution

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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