FDA.reportPublic FDA data

PERMA PURE

Primary DI
10840106906199
Brand
PERMA PURE
Company
PERMA PURE LLC
Model
ME Series
Catalog number
ME-050-03-229
Device description
4.3" ME with 1/16" Barbs
Published
2024-11-12
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
10840106906199PackageGS15In Commercial Distribution
20840106906196PackageGS110In Commercial Distribution
30840106906193PackageGS125In Commercial Distribution
40840106906190PackageGS150In Commercial Distribution
50840106906197PackageGS1100In Commercial Distribution
60840106906194PackageGS1250In Commercial Distribution
00840106906192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084010690619910840106906199
2084010690619620840106906196
3084010690619330840106906193
4084010690619040840106906190
5084010690619750840106906197
6084010690619460840106906194
00840106906192008401069061928401069061920840106906192

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
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
00840106906222PERMA PUREME SeriesME-110-03-1002024-11-07

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