Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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250 Gallon High Purity Distribution System w/ Variable Frequency Control. Features: 250 Gallon PP Storage Tank w/ calibration scale, pedestal stand, 2-22 GPM flowmeter, electronic pressure transmitter, pressure guage, injection assembly, run dry protection, flow regulator, 316SS distribution pump (3Ph) 2 hp w/ VFD controller.
SPECIALITY WATER TECHNOLOGY
A-UPT-22B1A-TEF
In Commercial Distribution

  • B297AUPT22B1ATEF0 ()


  • Combination water purification system
No Description
Paul Marienfeld GmbH & Co. KG
Microscope slides 75x25x1 ground edges 2xmarking area 20mm PP
In Commercial Distribution

  • 04250317388964 ()
  • 04250317302403 ()
1030618

  • General specimen microscopy slide IVD, single-use
Instrapac Delivery Pack - 18cm Forceps X 20 Contents: 1 x Umbilical Cord Scissors 10cm, 1 x Mayo Scissors Straight 17cm, 2 x Spencer Wells Forceps Straight 18cm, 2 x Umbilical Cord Clamps, 1 x PP tray with 2 Integral Pots. Provided in a crepe paper wrap.
ROBINSON HEALTHCARE LIMITED
7821
In Commercial Distribution

  • 05010058178212 ()
  • 05010058078215 ()
7821

  • Birthing/delivery kit
7017 Instrapac Delivery Pack - 18cm/7in Forceps. 20 Packs per Case. Contents: 1 x Umbilical Cord Scissors 10cm/4in, 1 x Mayo Scissors Straight 17cm/6.75in, 1 x Spencer Wells Forceps Straight 18cm/7in, 2 x Umbilical Cord Clamps, 1 x PP tray with 2 Integral Pots. Provided in a crepe paper wrap.
ROBINSON HEALTHCARE LIMITED
7017 Delivery Pack - 18cm/7in Forceps
In Commercial Distribution

  • 05010058170179 ()
  • 05010058070172 ()
7017

  • Birthing/delivery kit
The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary parts including breast shied, silicone valve, silicone membrane, bottle, bottle connector, connector pin, airtight cap, pp bottle, nipple, screw cap, cover, power adapter and instruction for use.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017714 ()
  • 08809108017710 ()
MM011500

  • Breast pump, electric
These drapes are composed of 2 layers: 1 absorbent spunlace layer (24g/m²) 1 waterproof PP layer (30g/m²) More info They can cover the equipment, Mayo tables, bridge tables and the patient Sticking on the shorter side For the whole range SURFACES PROTECTION For the product Effective barrier to fight against cross contaminations in non autoclavable elements, like dental chairs Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer 3 sizes, for all purposes Really strong and tear-resistant Compliant with the 13795-3 European norm
HYGITECH
HY-634
In Commercial Distribution

  • 03615140003827 ()
  • 03615140003810 ()
  • 03615140003834 ()
HY-634

  • Surgical drape adhesive
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution

  • B322D0011 ()


  • Pulse oximeter, line-powered
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