FDA.reportPublic FDA data

PRABADIN

Primary DI
10850051158208
Brand
PRABADIN
Company
Prabadin Corp
Model
PR0507-090
Device description
Guedel Airways, Latex free
Published
2024-05-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051158171PackageGS110In Commercial Distribution
10850051158208PackageGS150In Commercial Distribution
00850051158201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051158171008500511581718500511581710850051158171
1085005115820810850051158208
00850051158201008500511582018500511582010850051158201

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-547-8166sergio@medlife.us

Regulatory Flags#

DUNS number
100803924
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00850051158232PRABADINPR71AC-16P2024-05-17
00850051158058PrabadinOR Towel2023-04-28
00850051158119Prab-PadsPrab-Pads2023-08-25
00850051158126Prab-PadsPrab-Pads2023-08-25
00850051158249PRABADINPRGS4412PNS2024-05-17
00850051158256PRABADIN4HQ5-XXX2024-05-17
00850051158263PRABADIN2RFJ-4091002024-05-17
10850051158215PRABADINPR71AC-16P2024-05-17
10850051158246PRABADINPRGS4412PNS2024-05-17
10850051158253PRABADIN4HQ5-XXX2024-05-17
10850051158260PRABADIN2RFJ-4091002024-05-17
00850051158140PRABADINPR4GQ2-10C2024-05-06
00850051158157PRABADINPR0506-0652024-05-06
00850051158164PRABADINPR0506-0702024-05-06
00850051158201PRABADINPR0507-0902024-05-06
00850051158133PRABADINPRPG3242WT2024-05-06
00850051158195PRABADINPR4GQ2-10C2024-05-06
10850051158154PRABADINPR0506-0652024-05-06
10850051158161PRABADINPR0506-0702024-05-06
10850051158116Prab-PadsPrab-Pads2023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
05060112310065LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
05060112310607LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
15060112314183LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-01
05060112310041LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310621LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310638LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310645LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310652LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310683LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
15060112316200LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-30
05060112310072LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310089LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310096LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310119LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310157LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310164LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310171LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310188LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310195LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310201LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310676LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
10888277699472MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699489MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699496MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699502MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699533MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
15060112314176LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29