Antistatic Compact Space Chamber with Small Mask

Primary DI
00842135100015
Brand
Antistatic Compact Space Chamber with Small Mask
Company
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
Model
SP-ANTI-SSUS
Published
2017-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVPHolding Chambers, Direct Patient InterfaceAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143615000Antistatic Compact Space ChamberMedical Developments International Limited2016-01-26NVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842135100012PackageGS124In Commercial Distribution
00842135100015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084213510001210842135100012
00842135100015008421351000158421351000150842135100015

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
751908968
Device count
1
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842135100053myMDI Finger Pulse OximeterPO-FPO-US2017-04-13
00842135100008Antistatic Compact Space ChamberSP-ANTI-SUS2017-04-13
00842135100022Antistatic Compact Space Chamber with Medium MaskSP-ANTI-SMUS2017-04-13
00842135100039Antistatic Compact Space Chamber with Large MaskSP-ANTI-SLUS2017-04-13
00842135100084Antistatic Compact Space Chamber with Antistatic Small MaskSP-ANTI-SSUSMDI2023-08-07
00842135100091Antistatic Compact Space Chamber with Medium Antistatic MaskSP-ANTI-SMUSMDI2023-08-07
00842135100107Antistatic Compact Space Chamber with Large Antistatic MaskSP-ANTI-SLUSMDI2023-08-07
10842135100081Antistatic Compact Space Chamber with Antistatic Small MaskSP-ANTI-SSUSMDI2023-08-07
10842135100098Antistatic Compact Space Chamber with Medium Antistatic MaskSP-ANTI-SMUSMDI2023-08-07
10842135100104Antistatic Compact Space Chamber with Large Antistatic MaskSP-ANTI-SLUSMDI2023-08-07
10842135100012Antistatic Compact Space Chamber with Small MaskSP-ANTI-SSUS2017-04-13
10842135100050myMDI Finger Pulse OximeterPO-FPO-US2017-04-13

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00842135100091Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07
00842135100107Antistatic Compact Space Chamber with Large Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07