FDA.report

Timeter

Primary DI
00026072011980
Brand
Timeter
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
AD3500XJ
Catalog number
TE70A
Device description
Compressor
Published
2016-09-07
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
false

Related Records

Product Codes

CodeName
BTICompressor, Air, Portable

Product Code Classifications

CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00026072011980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072011980000260720119800260720119800026072011980

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
099674145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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