FDA.report

Perma Pure

Primary DI
00840106900800
Brand
Perma Pure
Company
PERMA PURE LLC
Model
ME Series
Catalog number
ME-050-03-43
Device description
12" ME W/ 1/16" BARBS
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840106900770PackageGS15In Commercial Distribution
00840106900787PackageGS110In Commercial Distribution
00840106900794PackageGS125In Commercial Distribution
00840106900800PackageGS150In Commercial Distribution
00840106900763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840106900770008401069007708401069007700840106900770
00840106900787008401069007878401069007870840106900787
00840106900794008401069007948401069007940840106900794
00840106900800008401069008008401069008000840106900800
00840106900763008401069007638401069007630840106900763

GMDN Terms

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

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 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 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