FDA.reportPublic FDA data

N/A

Primary DI
10607411891110
Brand
N/A
Company
SALTER LABS
Model
1217-0-25
Catalog number
1217-0-25
Device description
Hydrocolloid Strips. Only sold in packs of 25. Individual unit UDI: 00607411891113
Published
2016-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBHDEVICE, FIXATION, TRACHEAL TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411891110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060741189111010607411891110

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover adhesive strip, non-antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00N/A
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411966378IntuBrite SterileS01-6015.CS01-6015.C2018-12-13
00607411966385IntuBrite SterileS01-6016.CS01-6016.C2018-12-13
00607411966392IntuBrite SterileS01-6017.CS01-6017.C2018-12-13
00607411973055AirLifeSO-2169-0SO-2169-02026-05-11
00607411973062AirLifeSO-2170-0SO-2170-02026-05-11
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
00607411200915N/AL7600-0L7600-02016-09-24
00607411300738AirLifeSO-1500-0SO-1500-02016-11-30
00607411889097AirLifeSO-1188-0SO-1188-02016-11-30
00607411889103AirLifeSO-1189-0SO-1189-02016-11-30
00607411889110AirLifeSO-1190-0SO-1190-02016-11-30
00607411918025AirLifeSO-1968-0SO-1968-02016-11-30
00607411918070AirLifeSO-1972-0SO-1972-02016-11-30
00607411102035Salter Labs8107V-02026-04-24
00607411800870N/A1107-01107-02016-11-30
00607411001017N/A1003-0-501003-0-502016-12-16
10607411976237NebuTech8990TG-7-508990TG-7-502023-09-25
10607411001229Salter AIRE Elite8501-0-58501-0-52018-02-09
00607411001611N/ASO-461SO-4612016-09-24
00607411102103Salter AIRE Elite8352-8924-7-18352-8924-7-12016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428744947OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
00612479280571McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280601McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280632McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280663McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
10192253044591ArgyleCardinal Health 200, LLCCBH2025-08-26
00848530105853Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
10889483605141AirLife™AIRLIFECBH2025-03-18
10889483605134AirLife™AIRLIFECBH2025-03-13
00610075095834AnchorFast SlimFitHOLLISTER INCORPORATEDCBH2024-11-05
00610075095766AnchorFastHOLLISTER INCORPORATEDCBH2024-10-03
00610075095780AnchorFast GuardHOLLISTER INCORPORATEDCBH2024-09-03
00610075095810AnchorFast Guard SelectHOLLISTER INCORPORATEDCBH2024-09-03
10197344103607MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103614MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103621MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103638MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103645MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10197344103652MEDLINEMEDLINE INDUSTRIES, INC.CBH2024-08-01
10618125191625PoseyTIDI PRODUCTS, LLCCBH2024-05-03
10618125191670PoseyTIDI PRODUCTS, LLCCBH2024-05-03
00848530103514One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103521One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103538Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103545Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103552Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
00848530103569Two Piece Tracheostomy Tie Pediatric 2cm x 45.5cm (18in)SUNSET HEALTHCARE SOLUTIONS, INC.CBH2024-03-20
10840330703410ProCureTwin Med, LLCCBH2024-02-23
10840330703908ProCureTwin Med, LLCCBH2024-02-23
10840330703915ProCureTwin Med, LLCCBH2024-02-23