PFT

GUDID 05099169285729

2820 Eco BVF + DNC

VITALOGRAPH (IRELAND) LIMITED

Breathing mouthpiece, single-use

• Primary Device ID: 05099169285729
• NIH Device Record Key: d617b2ce-81cd-4569-a310-c05eced55efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT
• Version Model Number: 2820
• Company DUNS: 219683489
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169285729 [Package]; Contains: 15099169285726; Package: [80 Units]; In Commercial Distribution
GS1	15099169285726 [Primary]
GS1	55099169285724 [Package]; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942779

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-12-01

On-Brand Devices [PFT]

• 55099169285731: 2820 ECO PFT KIT MS
• 05099169285729: 2820 Eco BVF + DNC
• 05099169285712: 2820 Eco BVF LAB + DNC
• 05099169285521: 2820 ECO BVF LAB
• 05099169285507: 2820 ECO BVF
• 55099169284499: 2820 BVF (28401) + DNC
• 05099169284487: 2820 BVF (FOSTER) + DNC + OVAL MP
• 05099169284432: 2820 BVF (KOKO) + DNC + FRONT BITE-ON
• 05099169284425: 2820 BVF (MED GR) + DNC + FRONT BITE-ON
• 55099169284413: 2820 BVF (JAE) + DNC + FRONT BITE-ON
• 05099169284401: 2820 BVF (SM,PKM,Ga) + DNC + FRONT BITE
• 05099169284395: 2820 BVF(28365) + 2020 REAR BITE-ON + 2030 DISP NOSE CLIP
• 05099169284388: 2820 BVF (28365) + 2030 DISP NOSE CLIP + OVAL MP
• 05099169284371: 2820 BVF (28368) + OVAL MOUTHPIECE
• 55099169284369: 2820 BVF (28368) + 2030 NOSE CLIP
• 05099169284340: 2820 PFT KIT
• 05099169284326: 30/30 PFT KIT
• 05099169284319: 2820 BVF (28362) + OVAL M/P + 2030 DISPOSABLE NOSE CLIP
• 05099169284302: 2820 BVF (28365) + OVAL M/P
• 05099169284296: 2820 BVF (28363) + OVAL M/P
• 05099169284289: 2820 BVF (28362) + OVAL M/P
• 55099169284277: 2820 BVF (28350) + OVAL M/P
• 05099169284265: 2820 PFT KIT 25ID
• 05099169284258: 2820 PFT KIT TRANSL. BVF FRONT-BITE
• 55099169284215: 2820 PFT KIT 30/30
• 05099169284180: 2820 PFT KIT 30ID MEDISIZE
• 55099169284048: 2820 BV FILTER + OVAL M/P + 2030 NOSECLIP
• 55099169284031: 2820 BV FILTER (28363) + OVAL M/P + 2030 NOSE CLIP
• 05099169284029: 2820 BV FILTER (28350) + OVAL M/P + 2030 NOSE CLIP
• 05099169284005: 30/30 PFT KIT
• 05099169283855: 2820 BV FILTER(28363)+OVAL M/P+45 ELBOW+2030 NOSE CLIP
• 05099169283824: 2820 BVF PFT KIT 28363
• 55099169283812: 2820 BV FILTER + 2030 NOSE CLIPS PFT KIT (28362)
• 05099169283725: 2820 BV FILTER + 2030 NOSE CLIPS (28362 + 20243)
• 55099169283713: 2820 BV FILTER + 2030 NOSE CLIPS (28363 + 20243)
• 05099169283701: 2820 BV FILTER + 2030 NOSE CLIPS (28350 + 20243)
• 55099169285533: 2820 ECO BVF WITH BITE LIP + DNC
• 05099169285514: 2820 ECO BVF + BITE-ON MOUTHPIECE +DNC