FDA.reportPublic FDA data

RUSCH

Primary DI
14026704738066
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN922020
Catalog number
849100
Published
2026-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGPDressing, wound and burn, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGPDressing, Wound And Burn, OcclusiveUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942757000ASHERMAN CHEST BANDAGEAsherman Medical Products, LLC1994-08-01MGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704738063PackageGS110In Commercial Distribution
34026704738060PackageGS120In Commercial Distribution
14026704738066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670473806324026704738063
3402670473806034026704738060
1402670473806614026704738066

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax dressingA sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31
05060112310621LMA AIRWAY MANAGEMENTIPN9018661500252026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30884389803114MEDLINEMEDLINE INDUSTRIES, INC.MGP2024-08-06
00810050460033Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460101Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460118Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
10810050460030Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460108Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460115Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
00810050460019Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
00810050460026Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
00810050460040Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
00810050460057Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
10810050460016Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
10810050460023Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
10810050460047Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
10810050460054Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
00050428287071CVS Health™WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMGP2022-09-24
M7528900120Stradis Medical, LLC.STRADIS MEDICAL, LLCMGP2022-06-01
M7528900030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528900031STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528910030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528204040STRADIS STRADIS MEDICAL, LLCMGP2022-05-16
M7528900070STRADIS HEALTHCARESTRADIS MEDICAL, LLCMGP2022-03-31
00856525007365PFAB SMALLSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007372PFAB MediumSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007389PFAB Medium CrescentSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007396PFAB LargeSUN SCIENTIFIC, INC.MGP2021-04-30
05000223449889"ACTICOAT 4""X48"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565121536ACTICOAT 4"X48"SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565122045"ACTICOAT 3 5"" X 5"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16
05000223449766"ACTICOAT 4"" X 4"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16