FDA.reportPublic FDA data

PERMA PURE

Primary DI
00810020360578
Brand
PERMA PURE
Company
PERMA PURE LLC
Model
ME Series
Catalog number
ME-110-03-10
Device description
ME-110-03-10 Nafion Dryer
Published
2024-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810020360561PackageGS15In Commercial Distribution
00810020360585PackageGS110In Commercial Distribution
00810020360592PackageGS125In Commercial Distribution
00810020360578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810020360561008100203605618100203605610810020360561
00810020360585008100203605858100203605850810020360585
00810020360592008100203605928100203605920810020360592
00810020360578008100203605788100203605780810020360578

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Regulatory Flags#

DUNS number
063142533
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840106906277Nafion DryerME SeriesME-050-48BB 2025-08-29
00840106906253Nafion DryerME SeriesME-050-03-2832025-05-22
10840106906250Nafion DryerME SeriesME-050-03-2832025-05-22
00840106906246Nafion DryerME SeriesME-070-03-562025-03-20
10840106906243Nafion DryerME SeriesME-070-03-562025-03-20
00840106906031PERMA PUREME SeriesME-050-03-2822024-10-15
90840106905075PERMA PUREME SeriesME-070-48BB 2024-11-12
00840106906192PERMA PUREME SeriesME-050-03-2292024-11-12
10840106906199PERMA PUREME SeriesME-050-03-2292024-11-12
90840106905082PERMA PUREME SeriesME-070-48BB 2024-11-12
00840106905157PERMA PUREME SeriesME-050-03-2732024-11-07
00840106905164PERMA PUREME SeriesME-060-24-BB2024-11-07
00840106905171PERMA PUREME SeriesME-060-03-1112024-11-07
00840106905195PERMA PUREME SeriesME-060-03-732024-11-07
00840106905201PERMA PUREME SeriesME-110-03-372024-11-07
00840106905218PERMA PUREME SeriesME-110-03-172024-11-07
00840106905560PERMA PUREME SeriesME-110-18-BB2024-11-07
00840106906086PERMA PUREME SeriesME-070-03-242024-11-07
00840106906208PERMA PUREME SeriesME-110-03-2292024-11-07
00840106906215PERMA PUREME SeriesME-070-03-262024-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840106906253Nafion DryerPERMA PURE LLCCBQ2025-05-22
00840106906246Nafion DryerPERMA PURE LLCCBQ2025-03-20
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBQ2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBQ2024-12-19
90840106905075PERMA PUREPERMA PURE LLCCBQ2024-11-12
00840106906192PERMA PUREPERMA PURE LLCCBQ2024-11-12
00840106905157PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905164PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905171PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905195PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905201PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905218PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905560PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906086PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906208PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906215PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906222PERMA PUREPERMA PURE LLCCBQ2024-11-07
00810020360141PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905027PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905188PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905287PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905317PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905409PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905416PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905508PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905522PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905539PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905614PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905621PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905638PERMA PUREPERMA PURE LLCCBQ2024-11-06