FDA.report

Marpac Inc

Primary DI
00653658009057
Brand
Marpac Inc
Company
Marpac, Inc.
Model
905
Device description
Pediatric ventilator anti-disconnect device.
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CBHDevice, Fixation, Tracheal Tube
JAYSupport, Breathing Tube

Product Code Classifications

CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653658009057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653658009057006536580090576536580090570653658009057

GMDN Terms

TermDefinition
Tracheostomy tube neck holder, single-useA non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-505-344-4740sales@marpacmedical.com

Regulatory Flags

DUNS number
794035683
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00653658001020Marpac Inc1022023-04-03
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