Antistatic Compact Space Chamber with Large Antistatic Mask

Primary DI
10842135100104
Brand
Antistatic Compact Space Chamber with Large Antistatic Mask
Company
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
Model
SP-ANTI-SLUSMDI
Device description
Antistatic Compact Space Chamber with Large Antistatic Mask
Published
2023-08-07
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
false

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842135100104PackageGS124In Commercial Distribution
00842135100107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084213510010410842135100104
00842135100107008421351001078421351001070842135100107

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842135100053myMDI Finger Pulse OximeterPO-FPO-US2017-04-13
00842135100015Antistatic Compact Space Chamber with Small MaskSP-ANTI-SSUS2017-04-13
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
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