FDA.reportPublic FDA data

Sharn Inc

Primary DI
00817518021515
Brand
Sharn Inc
Company
Sharn Anesthesia
Model
LM-321-250-1
Catalog number
LM-321-250-1
Device description
LARYNGEAL MASK, SIZE 2.5 1/PK
Published
2018-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00817518021515PrimaryGS10
00817518021997Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817518021515008175180215158175180215150817518021515
00817518021997008175180219978175180219970817518021997

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-3671mailbox@sharn.com

Regulatory Flags#

DUNS number
107996118
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518020129Sharn IncBAT1-100BAT1-1002018-09-26
00817518022109Sharn IncS2020S20202018-11-16
00817518022123Sharn IncS2020-ES2020-E2018-11-16
00817518022147Sharn IncS2020-MS2020-M2018-11-16
00817518022161Sharn IncS2020-PS2020-P2018-11-16
00817518022550Sharn Anesthesia105604-EU2022-10-27
00817518022567Sharn Anesthesia105605-EU2022-10-27
00817518022574Sharn Anesthesia105606-EU2022-10-27
00817518022581Sharn Anesthesia105607-EU2022-10-27
00817518022598Sharn Anesthesia105608-EU2022-10-27
00817518022468SharnSelect45-18520SS2022-06-20
00817518022475SharnSelect45-18530SS2022-06-20
00817518022482SharnSelect45-18540SS2022-06-20
00817518022499SharnSelect45-18550SS2022-06-20
00817518022505SharnSelect45-18560SS2022-06-20
00817518022512SharnSelect45-18515SS2022-06-20
00817518022529SharnSelect45-18525SS2022-06-20
00817518022536SharnSelect45-185150SS2022-06-20
00817518022543SharnSelect45-185200SS2022-06-20
00817518021546Sharn IncPI-803S-6PI-803S-62018-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
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