AccessGUDID - DEVICE: INOcal (00810055280056)

GUDID

Device Identifier (DI) Information

Brand Name: INOcal
Version or Model: BOM-COM-0167
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BOM-COM-0167
Company Name: Mallinckrodt Manufacturing LLC

Primary DI Number: 00810055280056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015322416 *Terms of Use

Device Description: INOcal 10 PPM NO2 Calibration Gas

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):	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?
37266	Nitric oxide delivery unit, system-based	A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXK	Gas, Calibration (Specified Concentration)

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
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2937685-ebac-4584-8568-66c70f62c3fd
Public Version Date: July 26, 2022
Public Version Number: 1
DI Record Publish Date: July 18, 2022

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

Customer Contact

[?]

Phone: +1(877)566-9466
Email: CritCare-csmail@mnk.com

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

FDA TOOLS & RESOURCES