FDA.reportPublic FDA data

Perma Pure

Primary DI
00840106904556
Brand
Perma Pure
Company
PERMA PURE LLC
Model
ME Series
Catalog number
ME-050-03-270
Device description
ME-050-30MS/ML
Published
2019-10-09
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
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
00840106904525PackageGS15In Commercial Distribution
00840106904532PackageGS110In Commercial Distribution
00840106904549PackageGS125In Commercial Distribution
00840106904556PackageGS150In Commercial Distribution
00840106904518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840106904525008401069045258401069045250840106904525
00840106904532008401069045328401069045320840106904532
00840106904549008401069045498401069045490840106904549
00840106904556008401069045568401069045560840106904556
00840106904518008401069045188401069045180840106904518

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible tube(s) primarily intended to be used as an interface 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]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. 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
false
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
10840106906250Nafion DryerME SeriesME-050-03-2832025-05-22
10840106906243Nafion DryerME SeriesME-070-03-562025-03-20
10840106906199PERMA PUREME SeriesME-050-03-2292024-11-12
90840106905082PERMA PUREME SeriesME-070-48BB 2024-11-12
10840106905154PERMA PUREME SeriesME-050-03-2732024-11-07
10840106905161PERMA PUREME SeriesME-060-24-BB2024-11-07
10840106905178PERMA PUREME SeriesME-060-03-1112024-11-07
10840106905192PERMA PUREME SeriesME-060-03-732024-11-07
10840106905208PERMA PUREME SeriesME-110-03-372024-11-07
10840106905215PERMA PUREME SeriesME-110-03-172024-11-07
00810020360752PERMA PUREME SeriesME-110-18-BB2024-11-07
00840106906093PERMA PUREME SeriesME-070-03-242024-11-07
10840106906205PERMA PUREME SeriesME-110-03-2292024-11-07
10840106906212PERMA PUREME SeriesME-070-03-262024-11-07
10840106906229PERMA PUREME SeriesME-110-03-1002024-11-07
00810020360158PERMA PUREME SeriesME-070-12BB2024-11-06
00810020360561PERMA PUREME SeriesME-110-03-102024-11-06
00840106905034PERMA PUREME SeriesME-110-03-192024-11-06
10840106905185PERMA PUREME SeriesME-070-06-BB2024-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840106906277Nafion DryerPERMA PURE LLCCBQ2025-08-29
00817770026068Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)MAXTEC, LLCCBQ2025-07-21
10840106906250Nafion DryerPERMA PURE LLCCBQ2025-05-22
10840106906243Nafion DryerPERMA PURE LLCCBQ2025-03-20
10840106906199PERMA PUREPERMA PURE LLCCBQ2024-11-12
90840106905082PERMA PUREPERMA PURE LLCCBQ2024-11-12
10840106905154PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106905161PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106905178PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106905192PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106905208PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106905215PERMA PUREPERMA PURE LLCCBQ2024-11-07
00810020360752PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906093PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106906205PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106906212PERMA PUREPERMA PURE LLCCBQ2024-11-07
10840106906229PERMA PUREPERMA PURE LLCCBQ2024-11-07
00810020360158PERMA PUREPERMA PURE LLCCBQ2024-11-06
00810020360561PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905034PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905185PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905294PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905314PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905406PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905413PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905505PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905529PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905536PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905611PERMA PUREPERMA PURE LLCCBQ2024-11-06
10840106905628PERMA PUREPERMA PURE LLCCBQ2024-11-06