AccessGUDID - DEVICE: PORTRAIT AAB01 (00195278699916)

GUDID

Device Identifier (DI) Information

Brand Name: PORTRAIT AAB01
Version or Model: AAB01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5514165-30
Company Name: GE Healthcare Finland Oy

Primary DI Number: 00195278699916
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 401966697 *Terms of Use

Device Description: Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS

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?
37318	Electrode/transducer strap, single-use	A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
MSX	System, network and communication, physiological monitors
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)
DRG	TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
BZQ	Monitor, breathing frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230626	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
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -30 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b06ac6e1-151d-4fe0-b914-04687ead9d3f
Public Version Date: November 03, 2023
Public Version Number: 1
DI Record Publish Date: October 26, 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: 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

[?]

No Customer Contact currently defined

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