FDA.reportPublic FDA data

AirLife

Primary DI
00607411001154
Brand
AirLife
Company
SALTER LABS
Model
1008-0
Catalog number
1008-0-10
Device description
Salter Labs ™ Tender Grip® Newborn cannula fixation device
Published
2016-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
20607411001158PackageGS125In Commercial Distribution
00607411001154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2060741100115820607411001158
00607411001154006074110011546074110011540607411001154

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00N/A
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
022721133
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411201509Salter Labs Adult, ETC02 Nasal Sampling Cannula, female luer style connecSO-165090122016-09-24
00607411001147AirLife1007-01007-0-102016-11-30
00607411001024AirLife1005-01005-0-252016-11-30
10607411001045AirLife1016-0-251016-0-252016-11-30
10607411891714AirLife1017-0-251017-0-252016-11-30
10607411001038AirLife1006-0-1001006-0-1002016-11-30
10607411891110AirLife1217-0-251217-0-252016-11-30
00607411001048AirLife1016-01016-02019-04-29
00607411919039Salter Labs® High Concentration partial rebreather131202026-06-10
00607411919077Salter Labs® Nasal Cannula133002026-06-10
00607411919091Salter Labs® Nasal Cannula133042026-06-10
00607411919121Salter Labs® Nasal Cannula133092026-06-10
00607411919190Salter Labs® Nasal Cannula133372026-06-10
00607411919213Salter Labs® Nasal Cannula133472026-06-10
00607411919268Salter Labs® Oxygen Tubing134092026-06-10
00607411919282Oxygen Tubing Swivel Connector134452026-06-10
00607411919336Salter Labs® Percent-O2-Lock® Mask138152026-06-10
00607411919343Salter Labs® Full Kit Nebulizer139502026-06-10
00607411919367Salter Labs® Full Kit Nebulizer Set139522026-06-10
00607411919008Salter Labs® Adult Comfort Face Tent131032026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003756015KENOREXKENTRON HEALTHCARE, INC.CBH2026-06-01
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
00860009651630KC Airway Tape - Long-termKelCor, LLCCBH2026-01-22
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