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Pulmodyne Inc. devices, product family

by Pulmodyne Inc. 7 variants Basic UDI-DI 08414701DARTGT

Shared by every variant

Manufacturer
Pulmodyne Inc.(7)
Basic UDI-DI
08414701DARTGT
Risk class
Class IClass II (varies)
Legislation
—
EMDN category
—
Market status
7 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 08414701DARTGT.

Recalls

3 recalls · FDA

  • Z-0265-2010 unclassified · terminated · 5 Mar 2009
    Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
  • Z-0267-2010 unclassified · terminated · 5 Mar 2009
    Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
  • Z-0266-2010 unclassified · terminated · 5 Mar 2009
    Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.

Recalls matched to the 7 devices listed on this page; other pages of the family can carry others.

Variants

7 devices · page 1 of 1

Variants of Pulmodyne Inc. devices, Basic UDI-DI 08414701DARTGT
UDI-DISize and differences
DART DART100 DART10000841470100308 —On the market
DART DART110 DART11000841470100292 —On the market
DART DART140 DART14000841470100674 —On the market
DART DART300 DART30000841470100285 —On the market
DART-Reach REACH600 REACH60000841470100315
Length 218 mm
On the market
DART-Reach REACH700 REACH70000841470100322
Length 218 mm
On the market
DART-Reach REACH720 REACH72000841470100339
Length 117 mm
On the market