FDA.report

N/A

Primary DI
10607411001038
Brand
N/A
Company
SALTER LABS
Model
1006-0-100
Catalog number
1006-0-100
Device description
Tender Grip® 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

Related Records

Contact Domains

Product Codes

CodeName
CBHDEVICE, FIXATION, TRACHEAL TUBE

Product Code Classifications

CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10607411001038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060741100103810607411001038

GMDN Terms

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.

Storage And Handling

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

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
20889483224363MVAP Comfort Sleep Nasal CannulaHST332026-03-13
20889483225292MVAP Comfort Sleep Nasal CannulaSDC842026-03-13
20889483226435Bell Medical CannulaB180032C2026-03-13
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
10607411950503AirLife™2001-12001-12026-01-19
30889483236325Iradimed Adult Capnography Cannula1842A2025-08-04
30889483236332Iradimed Infant Capnography Cannula1842I2025-08-04
30889483236349Iradimed Pediatric Capnography Cannula1842P2025-08-04
30889483236356Iradimed1843A2025-08-04
30889483236363Iradimed1843P2025-08-04
30889483236370Iradimed1844A2025-08-04
30889483236387Iradimed1844P2025-08-04
30889483236318Iradimed Sample Line Extension18412025-08-04
30889483610569Resmed Sleep Apnealink Cannula707103162025-07-11
20889483569990O2 Cannula001321U2024-12-31
20889483570019O2 Cannula001322U2024-12-31
20889483570040O2 Cannula001326U2024-12-31
20889483570156O2 Cannula0013652024-12-31
20889483571375O2 Cannula002600-25U2024-12-31
20889483571504O2 Cannula0026922024-12-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08904428798438OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
00817612021121Dale Airway HolderDale Medical Products, Inc.CBH2026-03-11
00860013007652HORSESHOE ET Tube Securement Device + StrapSurgicure Technologies, Inc.CBH2026-03-04
00860013007676HORSESHOE Head StrapSurgicure Technologies, Inc.CBH2026-03-04
00850027043791Precision MedicalPrecision Medical, Inc.CBH2026-02-25
00850027043807Precision MedicalPrecision Medical, Inc.CBH2026-02-25
00612479280588McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280618McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280649McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00612479280670McKessonMCKESSON MEDICAL-SURGICAL INC.CBH2026-01-26
00860009651630KC Airway Tape - Long-termKelCor, LLCCBH2026-01-22
06979032640048GOBENHUZHOU JUNDA INDUSTRY CO., LTD.CBH2025-08-26
50192253044599ArgyleCardinal Health 200, LLCCBH2025-08-26
16974600043563KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043570KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043587KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043594KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043600KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-28
16974600043617KONLIDASuzhou Konlida Medical Supplies Co., Ltd.CBH2025-07-25
00860013007638HORSESHOE ET Tube Securement DeviceSurgicure Technologies, Inc.CBH2025-07-23
06978579510012ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
06978579510029ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
06978579510036ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
06978579510043ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedCBH2025-06-04
00848530105839Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
00848530105846Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
10848530105850Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
00848530105860Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CBH2025-06-03
00860013007614HORSESHOE ET Tube Securement DeviceSurgicure Technologies, Inc.CBH2025-06-03
30889483605145AirLife™Sunmed Group Holdings, LLCCBH2025-03-18