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
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