Home GUDID 00815277028059 Curaplex
Primary DI 00815277028059
Brand Curaplex
Company BOUND TREE MEDICAL, LLC
Model 8600-ATFMLOK
Device description *Custom* ATF Medic Load Out Kit 2016
Published 2016-12-14
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 true Product Codes# Code, Name table Code Name BTM Ventilator, emergency, manual (resuscitator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815277028059 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815277028059 00815277028059 815277028059 0815277028059
GMDN Terms# Term, Definition table Term Definition Home blood collection kit A collection of sterile devices and materials intended to be used by a layperson to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). It is normally available (non-prescription) over-the-counter (OTC) for use in the home. This is a single-use device.
Regulatory Flags# DUNS number 070556204 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 true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860012073535 butterflyBVM Compact Medical Inc. BTM 2026-03-13 00860012073559 butterflyBVM, PLUS Compact Medical Inc. BTM 2026-03-13 00860012073580 butterflyBVM, READY Compact Medical Inc. BTM 2026-03-13 44710810084629 N/A GALEMED CORPORATION BTM 2026-03-05 44710810084667 N/A GALEMED CORPORATION BTM 2026-03-05 44710810085770 N/A GALEMED CORPORATION BTM 2026-03-05 44710810119116 N/A GALEMED CORPORATION BTM 2026-03-05 34026704923893 RUSCH TELEFLEX INCORPORATED BTM 2026-02-18 24026704923773 RUSCH TELEFLEX INCORPORATED BTM 2026-02-13 24026704923780 RUSCH TELEFLEX INCORPORATED BTM 2026-02-13 24026704923797 RUSCH TELEFLEX INCORPORATED BTM 2026-02-13 20885632467353 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632467360 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632467377 HALYARD OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490719 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490740 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490757 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 20885632490764 Halyard OWENS & MINOR DISTRIBUTION, INC. BTM 2026-01-29 05707480152568 Ambu® SPUR® II Pediatric Resuscitator Ambu A/S BTM 2024-02-22 05707480145393 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145416 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145430 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145454 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145478 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145492 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145515 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145539 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145553 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145577 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13 05707480145591 SPUR® II Adult Resuscitator Ambu A/S BTM 2021-04-13