AccessGUDID - DEVICE: SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator (05707480034086)

GUDID

Device Identifier (DI) Information

Brand Name: SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator
Version or Model: 544211800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 544211800
Company Name: Ambu A/S

Primary DI Number: 05707480034086
Issuing Agency: GS1
Commercial Distribution End Date: October 10, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Ambu SPUR II Infant Tube Res.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36086	Pulmonary resuscitator, manual, single-use	A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTM	Ventilator, emergency, manual (resuscitator)

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
Handling Environment Temperature: between -18 and 50 Degrees Celsius
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Infant

Device Record Status

Public Device Record Key: b9954460-ac45-4b70-9715-30fbb9faa4fe
Public Version Date: October 11, 2019
Public Version Number: 4
DI Record Publish Date: December 19, 2016