FDA.reportPublic FDA data

Cannulaide

Primary DI
10607411007191
Brand
Cannulaide
Company
SALTER LABS
Model
CA110-0-1
Catalog number
CA110-0-1
Device description
Cannulaide Variety Pack Size 0, Size 1, Size 3
Published
2016-09-24
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
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143700000CPAP CannulaideSalter Labs2015-08-05BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411007191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060741100719110607411007191

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 intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607411007146CannulaideCA100-0-25CA100-0-252016-09-24
10607411007153CannulaideCA101-0-25CA101-0-252016-09-24
10607411007160CannulaideCA102-0-25CA102-0-252016-09-24
10607411007177CannulaideCA103-0-25CA103-0-252016-09-24
10607411007184CannulaideCA104-0-25CA104-0-252016-09-24
00607411301681N/A4950-7-74950-7-72016-09-24
00607411301698N/A4950F-7-74950F-7-72016-09-24
00607411301711N/A4950F-7-04950F-7-02016-09-24
00607411301728N/A4950-10-104950-10-102016-09-24
00607411301735N/A4950-14-144950-14-142016-09-24
00607411301742N/A4950F-14-144950F-14-142016-09-24
00607411301759N/A4950F-10-104950F-10-102016-09-24
00607411401367N/A49SOFT-FTG-10-1049SOFT-FTG-10-102017-11-21
00607411945397N/A49SOFT-7-7-049SOFT-7-7-02017-07-28
00607411945755N/A4950FTG-7-74950FTG-7-72017-07-28
00607411945816N/A49SOFT-14-1449SOFT-14-142017-08-28
00607411945823N/A49SOFT-F-7-749SOFT-F-7-72017-08-28
00607411947155N/A49SOFT-FTG-7-749SOFT-FTG-7-72017-11-21
00607411919145N/A4950TG-7-74950TG-7-72017-05-12
00607411919169N/A4950TG-14-144950TG-14-142017-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04