FDA.reportPublic FDA data

OneScope Pro

Primary DI
00860010859711
Brand
OneScope Pro
Company
One-AI Healthcare, Inc
Model
Pro - Neonatal Size 1 Blade
Catalog number
3010001
Device description
Pro - Neonatal Size 1 Blade
Published
2023-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010859711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010859711008600108597118600108597110860010859711

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope bladeA rigid, blade-like component of a bladed video intubation laryngoscope intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has an electronic camera at its distal end to transmit anatomical images by a video system to a connected video intubation laryngoscope handle/monitor. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
116913619
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010859704OneScope ProOneScope Pro Video Laryngoscope2023-10-03
00860010859728OneScope ProPro - Pediatric Size 2 Blade2023-10-03
00860010859735OneScope ProPro - Angulated Adult Size 3 Blade2023-10-03
00860010859742OneScope ProPro - Direct Adult Mac 3 Blade2023-10-03
00860010859759OneScope ProPro - Angulated Adult Size 4 Blade2023-10-03
00860010859766OneScope ProPro - Direct Adult Mac 4 Blade2023-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04719874957506Create BiotechCREATE BIOTECH CO., LTD.CCW2026-07-21
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
05051977003674PenlonPENLON LTDCCW2024-12-06
05051977003681PenlonPENLON LTDCCW2024-12-06
05051977003698PenlonPENLON LTDCCW2024-12-06
05051977003704PenlonPENLON LTDCCW2024-12-06
05051977003711PenlonPENLON LTDCCW2024-12-06
05051977003728PenlonPENLON LTDCCW2024-12-06
05051977003735PenlonPENLON LTDCCW2024-12-06
05051977003742PenlonPENLON LTDCCW2024-12-06
05051977003759PenlonPENLON LTDCCW2024-12-06
05051977003803PenlonPENLON LTDCCW2024-12-06
05051977003810PenlonPENLON LTDCCW2024-12-06
05051977003827PenlonPENLON LTDCCW2024-12-06
04250407786571FENTEXFENTEX medical GmbHLRC2024-08-01
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04250407737252FENTEXFENTEX medical GmbHLRC2022-12-12
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04250407737597FENTEXFENTEX medical GmbHLRC2022-12-12