FDA.report

Midmark

Primary DI
00841709108297
Brand
Midmark
Company
MIDMARK CORPORATION
Model
P32
Catalog number
P32
Device description
Midmark PowerAir Oil-Less Compressors are intended to provide compressed air during general examinations and procedures conducted by qualified dental professionals. Model: P32, Number of users: 3 - 5, Number of heads: 3, Total HP: 2.25, CFM @ 80psi: 7.8, Voltage: 208 - 230.
Published
2019-02-08
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
false

Related Records

Contact Domains

Product Codes

CodeName
NRDUnit, operative dental, accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841709108297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709108297008417091082978417091082970841709108297

GMDN Terms

TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature4 Degrees Celsius37 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius37 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags

DUNS number
005036025
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00841709122170Midmark153740-014153740-0142026-03-11
00841709121913MidmarkLT-1300-001LT-1300-0012026-03-10
00841709121937MidmarkLT-1400-102LT-1400-1022026-03-10
00841709121944MidmarkLT-1400-108LT-1400-1082026-03-10
00841709121951MidmarkLT-1400-114LT-1400-1142026-03-10
00841709121968MidmarkLT-1400-120LT-1400-1202026-03-10
00841709121975MidmarkLT-1400-126LT-1400-1262026-03-10
00841709121982MidmarkLT-1400-132LT-1400-1322026-03-10
00841709121999MidmarkLT-1500-096LT-1500-0962026-03-10
00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
00841709122019MidmarkLT-1500-108LT-1500-1082026-03-10
00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
00841709122033MidmarkLT-1500-120LT-1500-1202026-03-10

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