FDA.report

Mask, Value, Neonate

Primary DI
00612649215730
Brand
Mask, Value, Neonate
Company
King Systems Corporation
Model
1915
Catalog number
1915
Device description
MASK,VALUE,NEONATE
Published
2022-12-09
Public version status
Update
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
00612649168128PackageGS150In Commercial Distribution
00612649215730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649168128006126491681286126491681280612649168128
00612649215730006126492157306126492157300612649215730

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
009299017
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00612649190099BREATHING BAG510151012022-12-08
00612649190068BREATHING BAG509750972022-12-08
00612649190075BREATHING BAG509850982022-12-08
00612649190082BREATHING BAG509950992022-12-08
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