AccessGUDID - DEVICE: MOST (00860007698231)

GUDID

Device Identifier (DI) Information

Brand Name: MOST
Version or Model: MOST 20-2B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 793080-002
Company Name: Pacific Consolidated Industries LLC

Primary DI Number: 00860007698231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120848411 *Terms of Use

Device Description: MOST, 20-2B FINAL ASSEMBLY 10,000 LITERS AT 2250 PSI, 2 BRASS CYLINDERS

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:	No
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?
57850	Bulk oxygen concentration system	A stationary assembly of mains electricity (AC-powered) devices designed to concentrate oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 99.5%, to the hospital medical gas supply system. It may produce high-purity O2 using pressure swinging adsorption (PSA) technology which processes air through internal molecular sieves having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, refrigeration dryer, water and oil separators, high pressure O2 pump and various storage tanks. The concentrated O2 is delivered via the medical gas supply system to the user and/or a gas cylinder filling station.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, Oxygen, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040738	000

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: b3d7ea15-a75b-4188-a99f-b540cb1713aa
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES