FDA.reportPublic FDA data

Underarm Straps

Primary DI
08058323014282
Brand
Underarm Straps
Company
Intersurgical Incorporated
Model
CP900
Published
2023-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTKStrap, Head, Gas Mask

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058323030466PackageGS15In Commercial Distribution
08058323014282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058323030466080583230304668058323030466
08058323014282080583230142828058323014282

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia mask strap, reusableA band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
800-828-9633support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
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
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15M15111112026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15M15121112026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22F15131112026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22F15141112026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22F15151112026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22F15161112026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22F15171112026-06-10
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)82010302026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)82020302026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)82030302026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)82040302026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)82050302026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)82150302026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)82250302026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)89030302026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)89040302026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)89050302026-06-02
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE1997000S2026-04-28
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430352026-04-21
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY11410352026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109080CPAP HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2026-06-04
00848530109103CPAP HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2026-06-04
10889483002742Mask HarnessSUNMED, LLCBTK2026-03-19
00848530085902CPAP HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2025-11-12
06922166514068HeadgearSuzhou Yuyue Medical Technology Co., Ltd.BTK2025-10-10
06922166513894HeadgearSuzhou Yuyue Medical Technology Co., Ltd.BTK2025-09-30
06978333140011OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140028OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140004OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140035OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06946430423313CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
06946430423320CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423310CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423327CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
10889483606827AirLife™AIRLIFEBTK2025-03-03
10889483606841AirLife™AIRLIFEBTK2025-03-03
10889483606858AirLife™AIRLIFEBTK2025-03-03
10889483606865AirLife™AIRLIFEBTK2025-03-03
10889483606872AirLife™AIRLIFEBTK2025-03-03
10889483606896AirLife™AIRLIFEBTK2025-03-03
10889483606919AirLife™AIRLIFEBTK2025-03-03
30889483606821AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606845AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606852AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606869AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606876AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606890AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606913AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
00848530088743HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530080396HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30