FDA.reportPublic FDA data

Anesthesia

Primary DI
10848530094680
Brand
Anesthesia
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
AIS1010
Device description
Sunset Intubating Stylet - 10Fr
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSRStylet, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530094680PackageGS120In Commercial Distribution
20848530094687PackageGS1400In Commercial Distribution
00848530094683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853009468010848530094680
2084853009468720848530094687
00848530094683008485300946838485300946830848530094683

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
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
00848530110000Ventilator AccessoryVCMPV001-A2026-11-03
00848530110130Nasal CPAP MaskCM060-KITSLAB2026-11-03
00848530110147Oxygen KitCM060-KITLLAB2026-11-04
00848530110192CPAP MaskCM061SLAB2026-11-04
00848530110208CPAP MaskCM061MLAB2026-11-04
00848530110215CPAP MaskCM061LLAB2026-11-04
00848530110222CPAP MaskCM061XLLAB2026-11-04
00848530110284Oxygen KitAEAG002PKIT2026-11-03
00848530110291Oxygen KitAEAG002CKIT2026-11-03
00848530110307Breathing CircuitVEN004-CAP2026-11-03
00848530109875Ventilator accessoryVCMPV0012026-10-27
00848530110086Oxygen, Bacteria & HEPA FilterBF1412-32026-10-27
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840113242597BovieASPEN SURGICAL PRODUCTS, INC.BSR2026-09-04
04719874951061Create BiotechCREATE BIOTECH CO., LTD.BSR2026-07-21
04719874952914Create BiotechCREATE BIOTECH CO., LTD.BSR2026-07-21
00851232007165RTech REUSABLE INTUBATION STYLET D R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007172RTech STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007189RTech NON-STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007196J-WAND ADVANTAGE INTUBATION STYLET, NON-STERILED R BURTON HEALTHCARE, LLCBSR2026-04-28
10889483033302SunMedSUNMED, LLCBSR2026-02-18
10889483033319SunMedSUNMED, LLCBSR2026-02-18
10889483033326SunMedSUNMED, LLCBSR2026-02-18
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
00848530094676AnesthesiaSunset Healthcare Solutions, Inc.BSR2025-12-10
00848530094683AnesthesiaSunset Healthcare Solutions, Inc.BSR2025-12-10
00848530094690AnesthesiaSunset Healthcare Solutions, Inc.BSR2025-12-10
00848530094706AnesthesiaSunset Healthcare Solutions, Inc.BSR2025-12-10
10848530094673AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094697AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094703AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
04250105630442Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
04250105630459Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
04250105630435Ambu® SureSight TM Stylet; smallVBM Medizintechnik GmbHBSR2025-07-02
14250105630449Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
14250105630456Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
00860004198864Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23