FDA.reportPublic FDA data

Russel Pneumofix-8 (US)

Primary DI
05060483570402
Brand
Russel Pneumofix-8 (US)
Company
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
Model
PDF119
Catalog number
PDF119
Device description
The Russell PneumoFix®-8 is a sterile decompression needle composed of a veress-tipped needle inserted through an 8cm catheter, with a low-pressure release valve. The veress tip and indicator device assist with the safe insertion with a minimal risk of injuring the underlying lung, whilst the low-pressure release valve permits the release of tension pneumothorax with minimal potential of subsequent air re-entry.The Russell PneumoFix®-8 is composed of a stainless steel veress-tipped needle with a Tecoflex Polyurethane catheter. The catheter contains barium sulphate (20%) which enables the catheter to be visible during X-ray.
Published
2023-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCBNeedle, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCBNeedle, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483570402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483570402050604835704025060483570402

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219545612
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060483570365Russell Chest Seal (US Version)PDF0680PDF06802023-05-04
05060483570044Prometheus Pelvic SplintPRO400PRO4002024-10-27
05060483570181Prometheus Pelvic Splint (Tactical)PRO410PRO4102024-10-27
15060483570041Prometheus Pelvic Splint - Case of 40pcsPRO400PRO4002024-10-27
05060483571638TMT (Tactical Mechanical Tourniquet) PDF186PDF1862024-10-02
05060483571669TMT (Tactical Mechanical Tourniquet) - USPDF185PDF1852024-10-02
05060483571867TMT (Tactical Mechanical Tourniquet) PDF187PDF1872024-10-02
05060483571508SWAT-T TourniquetPDF165PDF1652024-09-03
05060483571515SWAT-T TourniquetPDF166PDF1662024-09-03
05060483570099Prometheus Omni Splint Rolled PDF105PML1052023-05-04
05060483570105Prometheus Omni Splint Flat PML115PML1152023-05-04
05060483570112Russell PneumoFix (US) PDF112PDF1122023-05-04
05060483570150Prometheus Steady Head PDF104PDF1042023-05-04
05060483570389Prometheus FullStop Tourniquet - BlackPDF180PDF1802023-05-04
05060483570396Prometheus FullStop Tourniquet - Hi VisibilityPDF181PDF1812023-05-04
05060483570051Prometheus Traction Splint PDF101PDF1012023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811084MONARCH™ Kit Catheter & AccessoriesAuris Health, Inc.GCB2026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitAuris Health, Inc.GCB2026-05-04
00884450820667MAK-NV™Merit Medical Systems, Inc.GCB2026-02-24
00661392008960LSL HEALTHCARELSL Industries, LLCGCB2025-10-30
10841156111830TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111847TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111854TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111861TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111837TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111844TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111851TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111868TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
14026704920263PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
14026704920270PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
00884450820643MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
10884450820640MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
00884450820568MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
10884450820565MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
00884450820612MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
10884450820619MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
00884450820636MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10884450820633MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10381780538493MicroFrance®INTEGRA MICROFRANCEGCB2024-05-29
10841156110949TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110956TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110963TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110970TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110946TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110953TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110960TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08