FDA.report

Vital Signs™

Primary DI
30889483585546
Brand
Vital Signs™
Company
Sunmed Group Holdings, LLC
Model
5210
Catalog number
5210
Device description
Vital Signs™ Neonate Face Mask Size 1
Published
2025-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483585546PackageGS120In Commercial Distribution
10190752147300PreviousGS10
10889483585542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948358554630889483585546
1019075214730010190752147300
1088948358554210889483585542

GMDN Terms

TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
119058668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
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30889483572164AirLife™0Y37700Y37702025-03-27

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