FDA.reportPublic FDA data

PERMA PURE

Primary DI
00810020360752
Brand
PERMA PURE
Company
PERMA PURE LLC
Model
ME Series
Catalog number
ME-110-18-BB
Device description
18" ME With 1/8" Barb Ends
Published
2024-11-07
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
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
00810020360752PackageGS15In Commercial Distribution
00810020360776PackageGS110In Commercial Distribution
00810020360783PackageGS150In Commercial Distribution
00810020360790PackageGS125In Commercial Distribution
00840106905560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810020360752008100203607528100203607520810020360752
00810020360776008100203607768100203607760810020360776
00810020360783008100203607838100203607830810020360783
00810020360790008100203607908100203607900810020360790
00840106905560008401069055608401069055600840106905560

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063142533
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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
00810020360578PERMA 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