AccessGUDID - DEVICE: MR Patient Care LoFlo CO2 with Airway Adapters (100) (20884838037834)

GUDID

Device Identifier (DI) Information

Brand Name: MR Patient Care LoFlo CO2 with Airway Adapters (100)
Version or Model: LoFlo Line Adu Airway Adpt, Box 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803185381
Company Name: Philips Ds North America LLC

Primary DI Number: 20884838037834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 013649151 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
42476	Breathing circuit catheter mount, single-use	A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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: 7ed11cae-2587-41f8-b58f-5e5d85f2e8c5
Public Version Date: February 01, 2024
Public Version Number: 8
DI Record Publish Date: December 26, 2016