FDA.reportPublic FDA data

PRABADIN

Primary DI
00850051158201
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
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.

Contacts#

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

Regulatory Flags#

DUNS number
100803924
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00850051158133PRABADINPRPG3242WT2024-05-06
00850051158195PRABADINPR4GQ2-10C2024-05-06
10850051158154PRABADINPR0506-0652024-05-06
10850051158161PRABADINPR0506-0702024-05-06
10850051158208PRABADINPR0507-0902024-05-06
10850051158116Prab-PadsPrab-Pads2023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704945310RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945327RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945334RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945341RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945358RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945365RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945372RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945389RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704624697RUSCHTELEFLEX INCORPORATEDCAE2026-07-22
04719874951504Create BiotechCREATE BIOTECH CO., LTD.CAE2026-07-16
04719874957575Create BiotechCREATE BIOTECH CO., LTD.CAE2026-07-16
15060112315029LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
15060112315036LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
15060112315043LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
10197344165605MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165612MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165629MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12